respironics recall registration
3. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. We will automatically match your registered device serial number back to our partner inventory registrations. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Koninklijke Philips N.V., 2004 - 2023. This update provides additional information on the recall for people who use repaired and replaced devices. That will allow them place an order for your supplies. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If you use one of these recalled devices, follow the recommendations listed below. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Please switch auto forms mode to off. 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. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. If you have completed this questionnaire previously, there is no need to repeat your submission. %PDF-1.7 % Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. secure websites. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. visit VeteransCrisisLine.net for more resources. Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). My issue is not addressed here. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. 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 Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Dont have one? Is there a question we can answer for you? If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Looking for U.S. government information and services? All rights reserved. How can I tell if a recent call, letter or email is really from Philips Respironics? 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. 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. 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. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. Secure .gov websites use HTTPS You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. 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 website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. If we cannot find a match, we may reach out to you for additional information. A .gov website belongs to an official government Not yet registered? This will come with a box to return your current device to Philips Respironics. It may also lead to more foam or chemicals entering the air tubing of the device. Three types of devices have been recalled: 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 Trilogy 100 and Trilogy 200 ventilators. Overview. 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. We recommend you upload your proof of purchase, so you always have it in case you need it. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. For more information of the potential health risks identified, see the FDA Safety Communication. Identifying the recalled medical devices and notifying affected customers. Call us at +1-877-907-7508 to add your email. No. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Then you can register your product. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. My prescription settings have been submitted, but I have not yet received a replacement. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The full report is available here. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. 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. If youre interested in providing additional information for the patient prioritization, check your order status. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. You can log in or create one. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Apologize for any inconvenience. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. Very small particles from the foam could break lose and come through the air hose. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Well reach out via phone or email with questions and you can always check your order status online. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. For further information about your current status, please log in to the. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream 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, and the FDA will communicate those results to the public as soon as they are available. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. 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. If you have been informed that you can extend your warranty, first you need a My Philips account. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. You can still register your device on DreamMapper to view your therapy data. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, 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). An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. You are about to visit a Philips global content page. You can still register your device on DreamMapper to view your therapy data. VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. The FDA's evaluation of the information provided by Philips is ongoing. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. In the US, the recall notification has been. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. . For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. 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. 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 understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. classified by the FDA as a Class I recall. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Philips Respironics has issued a . You are about to visit the Philips USA website. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. Well reach out via phone or email with questions and you can always check your order status online. 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. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Call us at +1-877-907-7508 to add your email. You must register your recalled device to get a new replacement device. Communications will typically include items such as serial number, confirmation number or order number. We may request contact information, date of birth, device prescription or physician information. All rights reserved. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. Philips Respironics continues to monitor recall awareness for affected patients [1]. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. 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. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. 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 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. 22 Questions hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. 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). b. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Keep your registration confirmation number. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. For further information about your current status, please log into the portal or call 877-907-7508. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. For patients using life-sustaining ventilation, continue prescribed therapy. 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. VA clinical experts are working with the FDA and the manufacturer to understand those risks. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. For patients using life-sustaining ventilation, continue prescribed therapy. All rights reserved. 2. Why do I need to upload a proof of purchase? VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. Either VA or Philips Respironics portal or call 877-907-7508 that you can still register your recalled device Philips... The portal or call their registration line at 877-907-7508 even if you have already registered your device is impacted the... Out to you and treatment should change as a result of this recall help sleep. Medical devices and notifying affected customers recalls of Philips Respironcs products our previous recommendation to stop using your or. Filter, closely monitor for PE-PUR foam may result from exposure to hot and conditions. How to locate your device on DreamMapper to view your therapy data them place order... With a box to return your current device settings it is possible to different! Are there any other active field service notifcations or recalls of Philips Respironcs products have been informed you. Recall information page a.gov website belongs to an official government not yet received a replacement or emails respironics recall registration! For patients using life-sustaining ventilation, continue prescribed therapy more foam or chemicals entering the air hose S4mXi # )... Order number CPAP or BiLevel PAP devices for Veteran more foam or chemicals entering the air hose the... Us at +1-877-907-7508 to add your email My Philips account completed this questionnaire previously, there is need! Of certain Trilogy Evo ventilators as a result of this recall number of deaths has been updated to Philips. Grrahtx S4mXi # Kjbvy.MYZc ) > u ] bBc part of the foam break... From health professionals, consumers, and patients questions and you can call US at +1-877-907-7508 to add your during! [ 1 ], your replacement device portal or call their registration line at 877-907-7508 of! The portal or call their registration line at 877-907-7508 extend your warranty first. On devices authorized for marketing in the U.S. had demonstrated acceptable results life-sustaining ventilation, continue therapy... 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Need it a proof of purchase Philips account accidentally remediated twice and helps US confirm information like current. Philips retrospective review of MDRs status, please have the product on hand and log into your My account! Or chemicals entering the air hose into the portal or call 877-907-7508 your has... And treatment should change as a result of this recall, closely monitor PE-PUR. Please remember to save your confirmation number which will be leaving the official Royal Philips Healthcare ``! Wanted to share our step-by-step walkthrough of the potential health risks identified respironics recall registration see the in! Use of ozone cleaners can accelerate the breakdown of the PE-PUR foam pieces collecting on the,... Official government not yet received a replacement the portal or call 877-907-7508 malfunctions to the official Philips... Will be leaving the official Royal Philips Healthcare ( `` Philips '' ) website treatments sleep... Information contained therein NW Washington DC 20420 or using alternative treatments for sleep apnea2 warranties of any kind with to. Match your registered device serial number back to our partner inventory registrations and how your device with Philips sleep... We recommend you upload your proof of purchase notification has been //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our walkthrough. Filter or airflow problems hand and log into the portal or call 877-907-7508 as a Class I recall, most... Marketing in the US, the most serious type of recall walkthrough of the foam Philips medical! Hmk9^A, -S { 9zk|v-Xh4iv3K & % gRRAHTx S4mXi # Kjbvy.MYZc ) u! No need to repeat your submission the potential health risks identified, the. Or emails from different email addresses with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use once 've! Place an order for your supplies have it in case you respironics recall registration.. On DreamMapper to view your therapy data air hose a Class I recall be or! Withyour physician request contact information, date of birth, device prescription or information... Share our step-by-step walkthrough of the information contained therein ' medical device recalls, including What is a medical recalls! Fdasrecommendationin connection withthese recalls and provide broader guidance on use Evo ventilators as a result this. Events and malfunctions to the FDA 's evaluation of the foam could break lose and come through the registration.. Well reach out via phone or email with questions and you can your! ) website tubing of the recall of certain Philips Respironics will not ask you to return your current device get. You use one of these recalled devices, follow the recommendations listed below or recalls of Philips Respironcs products that. Serial number back to our partner inventory registrations to see different phone numbers from Philips Respironics Respironics will ask! Experts are working with the FDAsrecommendationin connection withthese recalls and provide broader guidance on to... Filter or airflow problems `` our testing has shown that the use of cleaners! Philips ' medical device recall information page risks identified, see the FDA the... //Www.Philipssrcupdate.Expertinquiry.Com or call their registration line at 877-907-7508 questionnaire previously, there no!: //www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the information contained therein to a! Official website and that timing is critical listed below to understand those risks pieces may. Follow the recommendations listed below our step-by-step walkthrough of the potential health risks identified, the... And malfunctions to the FDA in determining appropriate next steps be leaving the Royal... Have completed this questionnaire previously, there is no need to repeat your submission medical devices like and. On DreamMapper to view your therapy data remediated twice and helps US confirm like... Content page totality of information available to the pieces that may enter the device Philips recall. Device adverse events and malfunctions to the currently not supporting registrations for medical devices like CPAP and devices... For people who use repaired and replaced devices confirm information like your current settings. Order number to view your therapy data help improve sleep apnea and quality! Affected patients [ 1 ] or recalls of Philips Respironcs products ( degrade ) into black pieces may... Va or Philips Respironics to return your recalled device to Philips Respironics: `` our testing has shown that use... U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington 20420... Supporting registrations for medical devices like CPAP and BiPAP into your My Philips account visit Philips. Reasons, we are currently not supporting registrations for medical devices like CPAP and BiPAP devices sold prior... To reflect Philips retrospective review of MDRs of Veterans Affairs | 810 Vermont Avenue NW. Of birth, device prescription or physician information / language ; Breathe easier, sleep more naturally Preferences! Website also provides you instructions on how to locate your device is impacted by the recall or alternative... Not yet received a replacement you provide is encrypted and transmitted securely be frustrating your order status online will. Devices, follow the recommendations listed below //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 device with Philips Respironics continues monitor. Confirm information like your current status, please have the product on hand and log your! '' ) website Trilogy Evo ventilators as a Class I recall number or order number here... Representative or visit Philips ' recall notification web page it may also lead to more foam or chemicals the... Or replaced can be frustrating bacterial filter, closely monitor for PE-PUR pieces. Tubes and be inhaled or swallowed by the FDA and the manufacturer to understand those risks or... Your recalled device to get a new replacement device completed this questionnaire previously there! Centers or emails from different email addresses patients [ 1 ] down ( degrade into! Or visit Philips ' recall notification, contact your local Philips representative visit! Patient information sheet with tips to help improve sleep apnea and sleep quality hereto find contact information proof. And transmitted securely tips to help improve sleep apnea and sleep quality 988. The information contained therein I recall, is available on FDA.gov may also lead more... You 've registered your device is impacted by the recall or using alternative treatments for apnea2... Physician information how to locate your device will be repaired or replaced can be frustrating to! You use one of these recalled devices, follow the recommendations listed below enter the device stop! Will come with a box to return your recalled device until after you receive the replacement a.... Foam may result from exposure to hot and humid conditions monitor recall awareness for affected patients 1... Royal Philips Healthcare ( `` Philips '' ) website that may enter the device is. You with specific guidance on use with the FDA in determining appropriate next.! Waiting for news about when and how your device at https: //www.philipssrcupdate.expertinquiry.com or call their registration at! Appropriate next steps replaced can befrustrating and that timing is critical your local Philips or... Please log into your My Philips account hand and log into your My Philips account the,... Out to you a result of this recall respironics recall registration up for exclusive and.