Apologize for any inconvenience. Register the device on the recall website www.philips.com/src-updates The website provides current information on the status of the recall and how to receive permanent corrective action to. Amsterdam, the Netherlands - In June 2021, Royal Philips' (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification in the US/field safety notice in other countries for certain sleep and respiratory care products to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in certain CPAP, BiPAP and . What devices have you already begun to repair/replace? The company anticipates the rework to begin this month. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). Shop now Item # DSX520H11C Not currently in stock Dreamstation 2 Auto CPAP with Humidifier Overview The Dream Family offers innovative, comprehensive sleep therapy technology like: . According to an CPAP machine FDA recall notice issued on June 30, 2021, the following Philips Respironics sleep apnea and breathing devices sold between 2009 and April 2021 may pose serious health risks: CPAP and BiPAP Device Recalls Non-Continuous ventilators: DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto Selected products Please be assured that our teams are working on a comprehensive remediation program to support patients with an affected device. We encourage you to read it if youre experiencing hardship during this recall.
Philips CPAP and BiLevel PAP Recall - VHA National Center for Patient The information is being updated on a regular basis and answered based on the latest safety communications from the FDA.
Receiving party's purpose of use of personal information: Store the collected information
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Philips Respironics Sleep Apnea Care Since the news broke, customers have let us know they are frustrated and concerned. We recommend you upload your proof of purchase, so you always have it in case you need it. 1875 Buckhorn Gate, 5th Floor, Mississauga, Ontario L4W 5P1. When you refuse to provide the authorization, you may have limited service provided through collection of personal information. What CPAP machines are on recall? Further testing and analysis is ongoing. Purpose of Collection and Use of Personal Information
The website will give you instructions on how to locate the serial number of your device. Create a new password following the password guidelines. Register your device on the Philips recall website or call 1-877-907-7508. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) . This process should take about 10 minutes to complete, but may vary based on internet speed or device used. While the CPAP recall is a frustrating experience, it does serve as an opportunity to switch up your CPAP equipment set-up so you can find the device that serves your needs best. Click Save. Doing this could affect the prescribed therapy and may void the warranty. Providing DreamMapper with the mask that you use for your therapy will allow us to assist you in obtaining good mask fit. Please note that once an RP kit is shipped for the affected Trilogy 100/200 device, the loaner Trilogy Evo must be returned within 45 days to avoid being charged. We are partnering with clinicians and business customers throughout this process to ensure were doing all we can to help you and your healthcare needs. Periodically, DreamMapper data is analyzed to determine where improvements can be made to the application and to determine the frequency that functions within the application is used. 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. Those risks include but are not limited to headaches, nausea, irritation of the eyes, nose or skin or potential cancer . Philips Respironics will continue with the remediation program. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary recall notification. 283% Product Support: 800-685-2999. First Night Guide. You can still register your device on DreamMapper to view your therapy data. You may have a high deductible or perhaps you have preferences for a specific vendor that isnt covered under your current policy. Please know that your health and safety is our main priority, as we work through this process. Additionally, Philips Respironics suggests patients review the age of their devices, as they are typically recommended to be replaced after five years of use. As a result, testing and assessments have been carried out. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. How can I register my product for an extended warranty? Since hearing the news we have been in daily communication with Philips Respironics to understand what aid we can provide our customers. With focusing all capacity on the recall, Houten said that approach has a consequence that we will not be able to serve new customers, so theres going to be a shortage in the field.. For those who cannot currently afford new equipment but who have been encouraged to continue their sleep apnea treatment, weve included a few solutions at the end of this article that we hope can be beneficial to you.
To register your device and check if your machine is included in the recall: Locate the serial number of your device.
Even Auto ON is enabled so that all you have to do is put your mask on and start breathing. 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. As a reminder, we recommend using a second device to read through the step-by-step instructions for an easier set up and transfer process. CPAP.com was recently notified by Philips Respironics of a recall for certain CPAP, APAP, and BiPAP devices. Then you can register your product. Access all your product information in one place (orders, subscriptions, etc. This foam is cleared for use by the FDA in the DreamStation 2 CPAP device and authorized as part of our remediation. Please visit mydreammapper.com by clicking the Login button above. You can refuse to provide the Authorization for Collection and Use of Personal Information. (This includes a request for temporary suspension of the 90-day adherence rule for continued coverage of a PAP device.). Philips reports that, "The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects." Philips reports that the foam-related complaint rate in 2020 was low (0.03%). Not all details of this recall are known at this time. Proof of purchase may be required to take advantage of a promotion or request a repair within warranty. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Note: If you are using a mask from another manufacturer, please select Mask Not Listed. Many of the Philips Respironics CPAP, APAP, and BiPAP machines sold from 2009 onward except the DreamStation 2 used this type of sound abatement foam and are impacted by this recall. To register your device and check if your machine is included in the recall: Philips Respironics plans to replace the current sound abatement foam with a new material that is not affected by this issue. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Please review the DreamStation 2 Setup and Use video for help on getting started. Koninklijke Philips N.V., 2004 - 2023. Have the product at hand when registering as you will need to provide the model number. December 2022 update on completed testing for first-generation DreamStation devices . 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. It is important to note that the tested DreamStation devices were not exposed to ozone cleaning. One of the more complex aspects of the recall has been creating remediation options for all variations of affected devices. Philips Respironics DreamStation 2 Auto CPAP Advanced with Humidifier BY Philips Respironics Item #DSX520H11C $1205.00 5 Reviews QTY 1 Out of Stock Prescription required Free Shipping Need replacement parts and accessories? All oxygen concentrators, respiratory drug delivery products, airway clearance products. Click Next. Philips Respironics Mask Selector uses no-touch. As this is an official recall, Philips Respironics must adhere to the regulatory requirements of a recall and specify the steps dealers, such as CPAP.com, must follow to adhere to the recall. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. In some cases, this foam showed signs of degradation (damage) and chemical emissions. Philips Respironics received authorization from the U.S. Food and Drug Administration (FDA) to restore affected first-generation DreamStation devices by replacing the PE-PUR sound abatement foam with a new material. We also offer frequent discounts on our machines, masks, and other CPAP accessories, which can help you save money on the equipment you need. You can register here. The FDA is still considering the data and analyses that Philips Respironics has provided and may reach different conclusions.
Don't have one? You can find the list of products that are not affected. 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.