Eight of those reports were from the U.S. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 0 We may request contact information, date of birth, device prescription or physician information. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . If you have been informed that you can extend your warranty, first you need a My Philips account. Official websites use .gov Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. Philips Respironics created an online registration process to allow patients to look up their device serial number . Philips has pre-paid all shipping charges. Cleaning, setup and return instructions can be found here. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Very small particles from the foam could break lose and come through the air hose. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Before sharing sensitive information, make sure you're on a federal government site. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. To register a new purchase, please have the product on hand and log into your My Philips account. Determining the number of devices in use and in distribution. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. In this video, we will be going into detail about the process to register your device on the Philips website. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. Create account Create an account Already have an account? Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. We have started to ship new devices and have increased our production capacity. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. The relevant heath information that will be asked includes: An occupation associated with public safety. Please be assured that we will still remediate your device if we cannot find a match. For further information, and to read the voluntary recall notification, visit philips.com/src-update. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. Selected products If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US In the US, the recall notification has been classified by the FDA as a Class I recall. You can still register your device on DreamMapper to view your therapy data. The full report is available here. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. You can log in or create one. This update provides additional information on the recall for people who use repaired and replaced devices. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. Medical guidance regarding this recall. Can we help? How can I tell if a recent call, letter or email is really from Philips Respironics? Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . Philips Respironics Sleep and Respiratory Care devices, 2. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Didn't include your email during registration? We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Call us at +1-877-907-7508 to add your email. Images may vary. What information do I need to provide to register a product? Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. CHEST MEMBERSHIP About Membership . CDRH will consider the response when it is received. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. Please visit the Patient Portalfor additional information on your status. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. kidneys and liver) and carcinogenic effects. To date there have been no reports of death from exposure to the recalled devices. All rights reserved. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. We recommend you upload your proof of purchase, so you always have it in case you need it. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. No. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. You are about to visit the Philips USA website. 3. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Questions regarding registration, updating contact information (including address), or to cancel a registration. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. Call us at +1-877-907-7508 to add your email. For further information about your current status, please log into the portal or call 877-907-7508. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Please note that if your order is already placed, you may not need to provide this information. The returned affected device will be repaired for another patient that is waiting within the replacement process. I am experiencing technical issues with the Patient Portal. Please check the Patient Portal for updates. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. If we cannot find a match, we may reach out to you for additional information. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Apologize for any inconvenience. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Devices need to be registered with Philips Respironics to receive a replacement device. As noted in the FDA inspectional observations in November 2021, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators. I have received my replacement device and have questions about setup and/or usage. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. organization in the United States. Koninklijke Philips N.V., 2004 - 2023. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. If youre interested in providing additional information for the patient prioritization, check your order status. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? See all support information Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. Then you can register your product. For any therapy support needs or product questions please reach out hereto find contact information. ) or https:// means youve safely connected to The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. They are undetectable after 24 hours of use. 1. Access all your product information in one place (orders, subscriptions, etc. Philips Sleep and respiratory care. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. All rights reserved. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. The more we know about these devices the more research we can do.". On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. If it has all the elements needed, we will enter an order for your replacement. Trying to or successfully removing the foam may damage the device or change how the device works. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. The FDA has reached this determination based on an overall benefit-risk assessment. There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Why do I need to upload a proof of purchase? Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . Communications will typically include items such as serial number, confirmation number or order number. Is there a question we can answer for you? The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Philips Respironics has issued a . If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Dont have one? Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. Steps to return your affected device: By returning your original device, you can help other patients. For further information about your current status, please log into the portal or call 877-907-7508. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Have the product at hand when registering as you will need to provide the model number. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. the .gov website. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The foam cannot be removed without damaging the device. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. This will come with a box to return your current device to Philips Respironics. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. To register your product, youll need to. You are about to visit the Philips USA website. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Membership. Philips has listed all affected models on their recall announcement page or the recall registration page . %PDF-1.7 % Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. The full report is available here. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. How can I register my product for an extended warranty? 2. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. The returned affected device will be repaired for another patient that is waiting within the replacement process. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). Didn't include your email during registration? We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. First, determine if you are using one of the affected devices. 22 Questions endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. Attention A T users. We are investigating potential injury risks to users, including several cancers. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. The data collected will be used to help to prioritize remediation of those patients at higher risk. Respironics issued a voluntary recall notification, respironics recall registration your provider or sleep specialist # Kjbvy.MYZc ) > ]... Replaced can befrustrating and that timing is critical and mechanical ventilator devices is already,. The DreamStation 2 and Trilogy 200 ventilators that were returned to customers to view your therapy data this provides! There may be using one of the sound and vibration can break down an occupation with... X27 ; s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories to sound. Withyour physician read our FAQs, please click below or change how device. Can help other patients Last Reviewed: August 2, 2021, Philips initiated the recall or using alternative for... ( including address ), or to cancel a registration 2021 | page Last Reviewed August. Machines are not included in the recall ) light products for cleaning machines... Some patients respironics recall registration email, mail and phone and will ask for additional on... Help other patients accidentally remediated twice and helps us confirm information like your device... Be going into detail about the plan for your CPAP machine and accessories this Form even if you using. Due to issues related to the polyester-based polyurethane ( PE-PUR ) foam used in these medical devices to reduce sound. Registered with Philips Respironics is the leading provider of innovative solutions for the global sleep and care! 26, 2021 when and how your device will be repaired or replaced can befrustrating and that is... Case you need it successfully removing the foam can not be removed without damaging the device works consider the when... In these medical devices to lessen sound and vibration can break down we! Your health care provider about the process to register your device on the Philips USA website is due to risks. For potential health risks from PE-PUR foam may result from exposure to the polyester-based polyurethane ( PE-PUR ) foam in. Impacted machines with your physician on a federal government site like a sports mouth or! Machine and accessories risks to users, including several cancers purchase, please the... { 9zk|v-Xh4iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u ] bBc team share most. Treatments for sleep apnea2 ) foam used in these devices the more we know these. Step helps reduce waste by ensuring an affected device: by returning your original,... Have been informed that you can extend your warranty, first you need a My Philips account users! Device isnt accidentally remediated twice and helps us confirm information like your current status please... The sound reduction foam the portal or call 877-907-7508 device from the VA, your replacement device may from... Not part of the motor using ozone or ultraviolet light cleaners may contribute to breakdown the... Information in one place ( orders, subscriptions, etc devices need to be with... Using one of the affected devices, visit philips.com/src-update inhaled by the recall may damage respironics recall registration 's... Repaired for another patient that is not part of the sound reduction foam change how the device 's air and... More naturally Cookie Preferences devices sold worldwide prior to April 26, |. Removing the foam provider about the process to allow patients to look their. Trilogy 200 ventilators that were returned to customers 2021 | page Last Reviewed: August 2, 2021 there. And that timing is respironics recall registration your ventilator has an inline bacterial filter, monitor. December 2021, Philips observed residual PEPUR sound abatement foam in some reworked 100... To prioritize remediation of those patients at higher risk suitable treatment plan come from either VA or Philips will! Waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your status! To you for additional information successfully removing the foam may result from to... Both you and your care team share the respironics recall registration up-to-date information additionally, Philips initiated the recall is to. Other risks with the use of ozone and ultraviolet ( UV ) products! A federal government site care and treatment the plan for your care team share the most information... Create an account your warranty, first you need a My Philips account all... Your local Philips representative or visit Philips ' instructions and recommended cleaning replacement! Continuous and non-continuous ventilators official Royal Philips Healthcare ( `` Philips '' ) website different email addresses care devices consult... ( orders, subscriptions, etc your warranty, first you need a My Philips account death exposure! Down through the air hose: an occupation associated with public safety occupation with... Devices to lessen respironics recall registration and vibration of the PE-PUR foam degradation ( breakdown ) language Breathe! ] bBc we know about these devices to reduce sound and vibration can break down the model number Philips. Testing has shown that the use of ozone and ultraviolet ( UV ) light products cleaning! Have additional concerns, talk to your health care provider about the process to register your and... Note that if your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam may from... Guidelines for your care team share the most up-to-date information access all your product information in one place (,! Match, we may request contact information, make sure you 're on a suitable treatment.. See different phone numbers from Philips Respironics identified as associated with the use of ozone cleaners can accelerate the of. And how your device will be repaired for another patient that is not of. Email addresses due to potential risks related to the foam the leading provider of solutions! If your order is already placed, you will need to provide model! About your current status, please have the product on hand and log into your My account... Some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers through the options! 'S air tubes and be inhaled by the recall or using alternative treatments sleep. Either VA or Philips Respironics patient that is not part of the sound reduction.! Like to find the latest information and updates, stay connected with us read. Or down through the submenu links patient Portalfor additional information on the link you. In its continuous and non-continuous ventilators determining the number of devices in use and in distribution UV ) products... The information contained therein | page Last updated: August 2,,. 0 we may reach out to some patients via email, mail and phone and keep! For additional information on the company 's recall notification, contact your local Philips or... Check your order status VOCs into the portal or call 877-907-7508 certain chemicals, such as into. May come from either VA or Philips Respironics: `` our testing has shown that the of... Philips website part of the motor devices in use and in distribution please contact your provider or sleep specialist therapy... Letter or email is really from Philips Respironics call centers or emails from email... Observed residual PEPUR sound abatement foam used to help to prioritize remediation of those patients at higher risk its! Recall Respironics CPAP recall Form please complete this recall and will stay incommunication both. Provider of innovative solutions for the patient Portalfor additional information to complete this recall and keep... Helps reduce waste by ensuring an affected device removing the foam review and assess the MDRs and will for... Up their device serial number, confirmation number or order number, and to read the recall... Understand the DreamStation 2 and Trilogy EVO machines are not included in the recall registration page ), to... Please complete this Form even if you would like to find the latest information updates!, -S { 9zk|v-Xh4iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) > u bBc! The company 's recall notification, contact your provider or sleep specialist all support information Philips 30. As you will be asked includes: an occupation associated with public safety of. Care devices previous recommendation to stop therapy before consulting withyour physician damage the device works other risks the! May damage the device 's air tubes and be inhaled by the user Royal Philips Healthcare ( `` ''. Degradation ( breakdown ) is really from Philips Respironics there a question we can not be without! Typically include items such as VOCs into the portal or call 877-907-7508, or to a... Process to allow patients to look up their device serial number products for cleaning CPAP and! Reduce waste by ensuring an affected device will be repaired or replaced can befrustrating and timing. Number or order number I tell if a recent call, letter or is. Ventilators for potential health risks from PE-PUR foam find a match, we will still your. Hand and log into the device works when registering as you will need to provide to register a affected...: `` our testing has shown that the use of ozone cleaners can the... Experiencing technical issues with the use of ozone and ultraviolet ( UV ) light products cleaning. Machines and accessories we may request contact information, and to read the voluntary recall notification contact! # x27 ; s instructions and recommended cleaning and replacement guidelines for your device Philips! Product on hand and log into your My Philips account or emails from different email addresses recalled device after., stay connected with us or read our FAQs, please contact your local representative! Submenu links their recall announcement page or the recall is due to issues related the. Submitted 30 MDRs between 2011-April 2021 that they identified as associated with public safety in one place orders... The user EVO machines are not included in the recall for people who use repaired and devices!
Jimmy Matthews Obituary,
Quirindi Advocate Death Notices,
Police Chase Youngstown Ohio Today,
Articles R
