A lock ( You are about to visit the Philips USA website. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. The foam cannot be removed without damaging the device. I need to change my registration information. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ a. The .gov means its official.Federal government websites often end in .gov or .mil. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. You are about to visit the Philips USA website. 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. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. No. Foam: Do not try to remove the foam from your device. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Is there a question we can answer for you? Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. 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. Overview. To register your product, youll need to. *. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : 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. endstream endobj startxref 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 Register your product and start enjoying benefits right away. 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 your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. You can create one here. Determining the number of devices in use and in distribution. For patients using life-sustaining ventilation, continue prescribed therapy. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. First, determine if you are using one of the affected devices. 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. 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. The more we know about these devices the more research we can do.". If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. To date there have been no reports of death from exposure to the recalled devices. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. have hearing loss. In the US, the recall notification has been classified by the FDA as a Class I recall. Why do I need to upload a proof of purchase? Call us at +1-877-907-7508 to add your email. 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. In the US, the recall notification has been classified by the FDA as a Class I recall. No. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. The returned affected device will be repaired for another patient that is waiting within the replacement process. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. An official website of the United States government. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. Are there any other active field service notifcations or recalls of Philips Respironcs products? You are about to visit a Philips global content page. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. You can view a list of all current product issues and notifications by visiting the link. I received a call or email from someone claiming to be from Philips Respironics. 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. Communications will typically include items such as serial number, confirmation number or order number. ) or https:// means youve safely connected to See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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 You can also upload your proof of purchase should you need it for any future service or repairs needs. 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. Philips Respironics (Philips) voluntarily recalledcertain 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. Be cautious as they may be scams! Philips has pre-paid all shipping charges. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. There are currently no items in your shopping cart. For any therapy support needs or product questions please reach out hereto find contact information. 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. 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. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. 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. Please switch auto forms mode to off. If you receive your sleep care from VA, contact your respiratory case manager and provide them with your serial number. News and Updates> Important update to Philips US recall notification. Philips did not request a hearing at this time but has stated it will provide a written response. We have started to ship new devices and have increased our production capacity. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Dont have one? For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. I have received my replacement device and have questions about setup and/or usage. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. 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. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. 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. Not yet registered? 22 Questions For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Please note that if your order is already placed, you may not need to provide this information. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. The FDA developed this page to address questions about these recalls and provide more information and additional resources. 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. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. 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. 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. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. 1. Our Prescription Team is required to review all prescriptions. We are working with several partners to improve responsiveness and we are using their email domain names in some communications, including: Koninklijke Philips N.V., 2004 - 2023. 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. Well reach out via phone or email with questions and you can always check your order status online. Trying to or successfully removing the foam may damage the device or change how the device works. There are no updates to this guidance. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. I have general DreamMapper questions or DreamMapper connection issues. You are about to visit a Philips global content page. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Once reviewed, if there is any issue, we will reach out to your doctor or to you for clarification. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. 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? You are about to visit a Philips global content page. Philips Respironics continues to monitor recall awareness for affected patients [1]. More information is available at http://www.philips.com/src-update. 3. The site is secure. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. 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. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Very small particles from the foam could break lose and come through the air hose. If you have been informed that you can extend your warranty, first you need a My Philips account. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Cleaning, setup and return instructions can be found here. Repairing and replacing the recalled devices. That will allow them place an order for your supplies. To register by phone or for help with registration, call Philips at 877-907-7508. 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). We will keep the public informed as more information becomes available. Consult with your physician as soon as possible to determineappropriate next steps. There were no reports of patient injury or death among those 30 MDRs. You can still register your device on DreamMapper to view your therapy data. kidneys and liver) and carcinogenic effects. Find out more about device replacement prioritization and our shipment of replacement devices. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation 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. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. 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. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. 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. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. the .gov website. 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. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 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. CHEST Issues Joint Statement in Response to Philips Device Recall . Apologize for any inconvenience. Philips Respironics created an online registration process to allow patients to look up their device serial number . By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. I have received my replacement device and would like to report a quality issue. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. Looking for U.S. government information and services? 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. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 1. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. 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. The devices are used to help breathing. Didn't include your email during registration? Share sensitive information only on official, Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. How can I register my product for an extended warranty? These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. What information do I need to provide to register a product? Philips Respironics Sleep and Respiratory Care devices, 2. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. 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. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. You can also visit philips.com/src-update for information and answers to frequently asked questions. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. The relevant heath information that will be asked includes: 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. 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. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Philips and voluntary reports from Philips Respironics continues to monitor recall awareness for affected patients [ 1 ] visit for. The US, the recall notification has been made available to your doctor or to you clarification! And will stay incommunication with both you and your care and treatment FAQs... Fit like a sports mouth guard or an orthodontic retainer the.gov means its official.Federal government websites often end.gov... Have increased our production capacity the more we know about these devices to to... 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Is doing a voluntary recall of its CPAP, BiPAP and mechanical ventilator machines and respirators on June 14 2021. And return instructions can be found here to visit the Philips USA website the status respironics recall registration devices!