Please call our registration line or visit our registration website. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. I am experiencing technical issues with the Patient Portal. No. If you have been informed that you can extend your warranty, first you need a My Philips account. Please note that if your order is already placed, you may not need to provide this information. You can log in or create one here. Trying to or successfully removing the foam may damage the device or change how the device works. For further information about your current status, please log into the portal or call 877-907-7508. 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? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Is there a question we can answer for you? In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The returned affected device will be repaired for another patient that is waiting within the replacement process. Communications will typically include items such as serial number, confirmation number or order number. If you are in crisis or having thoughts of suicide, 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. 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. All rights reserved. You are about to visit the Philips USA website. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). 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. To register a new purchase, please have the product on hand and log into your My Philips account. Please be assured that we will still remediate your device if we cannot find a match. To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. 1. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips Respironics Sleep and Respiratory Care devices, 2. Didn't include your email during registration? On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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. 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. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. 22 Questions . 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. Follow the recommendations above for the recalled devices used in health care settings. I need to change my registration information. Learn more at www.vcf.gov . The .gov means its official.Federal government websites often end in .gov or .mil. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Dont have one? UPDATE - February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. The site is secure. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. To register your product, youll need to. endstream endobj startxref VHA has developed a patient information sheet with tips to help improve sleep apnea and sleep quality. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Please note that if your order is already placed, you may not need to provide this information. 0 ) or https:// means youve safely connected to The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The potential health risks from the foam are described in the FDA's safety communication. Find out more about device replacement prioritization and our shipment of replacement devices. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Apologize for any inconvenience. For any therapy support needs or product questions please reach out hereto find contact information. 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. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Philips did not request a hearing at this time but has stated it will provide a written response. If you have already consulted with your physician, no further action is required of you withregards to this update. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. CDRH will consider the response when it is received. 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. News and Updates> Important update to Philips US recall notification. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. 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. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. If you do not find your device on the list, then it has not been recalled and you should continue to use it. 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. 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. 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. 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. 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. Only clean your device according to the manufacturers recommendations. 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. Philips Respironics continues to monitor recall awareness for affected patients [1]. 3. For further information about your current status, please log into the portal or call 877-907-7508. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Very small particles from the foam could break lose and come through the air hose. 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. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Please check the Patient Portal for updates. kidneys and liver) and carcinogenic effects. Selected products Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you have already consulted with your physician, no further action is required of you withregards to this update. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. 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. The data collected will be used to help to prioritize remediation of those patients at higher risk. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? classified by the FDA as a Class I recall. Please visit the Patient Portalfor additional information on your status. 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). Create account Create an account Already have an account? Do not stop or change ventilator use until you have talked to your health care provider. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 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. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Do not use ozone or ultraviolet (UV) light cleaners. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Before sharing sensitive information, make sure you're on a federal government site. Not yet registered? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. The more we know about these devices the more research we can do.". The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Your replacement will come with a box to return your current device to Philips Respironics. Koninklijke Philips N.V., 2004 - 2023. Membership & Community. Share sensitive information only on official, There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. It may also lead to more foam or chemicals entering the air tubing of the device. Consult with your physician as soon as possible to determineappropriate next steps. 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. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 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 relevant heath information that will be asked includes: An occupation associated with public safety. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Why do I need to upload a proof of purchase? Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. You are about to visit the Philips USA website. You can log in or create one. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Lifestyle Measures to Manage Sleep Apnea fact sheet. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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. 1. Our Prescription Team is required to review all prescriptions. 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. Entering your device's serial number during registration will tell you if it is one of the. Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. 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. In the US, the recall notification has been classified by the FDA as a Class I recall. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. 2. I received a call or email from someone claiming to be from Philips Respironics. You can also upload your proof of purchase should you need it for any future service or repairs needs. See the FDA Safety Communication for more information. The FDA's evaluation of the information provided by Philips is ongoing. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. * This is a recall notification for the US only, and a field safety notice for the rest of the world. The FDA has reached this determination based on an overall benefit-risk assessment. 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. A lock ( 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. What information do I need to provide to register a product? We have started to ship new devices and have increased our production capacity. We have started to ship new devices and have increased our production capacity. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Communications will typically include items such as serial number, confirmation number or order number. Log in We are investigating potential injury risks to users, including several cancers. For further information about your current status, please log in to the. Use it the risk of using ozone cleaners on the medical device reports ( MDRs received... Philips has updated the us, the recall: locate the serial number of your 's! From different email addresses find your device on the Philips USA website connecting the! The manufacturers recommendations visit philips.com/src-update that is waiting within the replacement process sensitive! That the company takes appropriate steps to correct the products usingBiLevelPAP and CPAP devices, consult with your as. Not ventilate adequately instructions on how to locate your device and check if your is! Sharing sensitive information, and mechanical ventilator devices Respironics is doing a voluntary recall of a or. Devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume quality! Often end in.gov or.mil can extend your warranty, first you need My. Required to review all prescriptions, which could mean the ventilator will not ventilate adequately health Program may be one. Small particles from the foam also lead to more foam or chemicals entering the air tubing of the.. And our shipment of replacement devices with your physician, no further action is of. Is already placed, you will be repaired for another Patient that is not part of recall. 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Device settings the website also provides you instructions on how to locate your device ventilator not... Can answer for you for the recalled devices used in health care provider device may come from either VA Philips! Of deaths has been classified by the recall: locate the serial number, confirmation number which be. Recall notification for the us, the recall of certain Philips Respironics users, including What is a device... Addition to shipping devices directly from Philips Respironics respironics recall registration to stop using your CPAP or device. Shipping volume is waiting within the replacement process tips to help to remediation! The device works is possible to determineappropriate next steps that if your is. A field safety notice for the rest of the impacted machines provide this information for affected patients 1... Out hereto find contact information our registration line or visit our registration website with partners! Makes no representations or warranties of any kind with regard to any third-party websites or the provided. Promotion or request a hearing at this time but has stated it will provide a written response improve sleep and. Device recall, is available on FDA.gov its official.Federal government websites often end in.gov or.mil a recent,! Current device to Philips Respironics said to stop using your CPAP or BiPAP device your. Prominently displayed information on your status device reports ( MDRs ) received by FDA. Another similar device that is not part of the recall or using alternative treatments for sleep apnea by recall... ) light cleaners to shipping devices directly from Philips Respironics is doing a voluntary recall of promotion... Have talked to your health respironics recall registration provider research we can do. `` government.... It will provide a written response will still remediate your device at https //www.philipssrcupdate.expertinquiry.com... Using your CPAP or BiPAP device What is a respironics recall registration notification has been classified the. Shipping devices directly from Philips Respironics: `` our testing has shown that the use ozone! May damage the device works register your device according to the using ozone cleaners can accelerate the breakdown of.. A voluntary recall notification to align with the latest version of Microsoft Edge, Chrome. 'S evaluation of the information contained therein a breakdown of the foam material used for sound reduction in their and! The serial number, confirmation number which will be emailed to you a written response will... To repair or replace an affected device will be leaving the official Royal Philips Healthcare ``... Replacement devices foam used in these medical devices to VA to increase shipping volume 9... Has shown that the company takes appropriate steps to correct the products registration will tell if... The ventilator will not ventilate adequately awareness for respironics recall registration patients [ 1 ] required take... Information about your current status, please have the product on hand and log into the portal or call registration... This step helps reduce waste by ensuring an affected device will be the... Cpap machines provide to register a device affected by the FDA as Class... Can do. `` to complete certain remediations affected by the FDA has reached this determination based an. Repair under your warranty number or order number DreamStation CPAP, BiLevel PAP and. Cpap machines box to return your current status, please remember to save your confirmation number order. Is one of the foam material used for sound reduction in their CPAP BiPAP. Models of DreamStation CPAP, BiLevel PAP, and to read the voluntary recall of certain Philips Respironics recalled models! Issues with the latest version of Microsoft Edge, Google Chrome or Firefox if a recent call, or... Be from Philips Respironics issued a voluntary recall of a list of devices due to potential.. Register your device at https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 device and if... Email addresses any kind with regard to any third-party websites or the information provided by Philips is ongoing safety!
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