URGENT: Medical Device Recall
Philips Respironics CPAP and Bi-Level PAP Devices
9/1/2021 UPDATE
Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation ONE, which consists of replacement of the PE-PUR sound abatement foam with a new material. More than 80% of the registered affected devices in the US to date are in the first-generation DreamStation product family. The company intends to complete the repair and replacement programs within approximately 12 months.
UPDATE 8/17/2021,
Philips is still waiting for FDA’s approval for the new sound abatement foam. Philips has tripled their production power of this new foam and is waiting for a green light from the FDA. We don’t have any information on which machines will be replaced and which ones will be repaired.
8/13/2021 UPDATE
Philips has start shipping replacement CPAP machines. You will be notified by Philips when your replacement machine will be processed for shipment to you.
8/12/2021 UPDATE
PHILIPS does NOT recommend using a bacteria filter outside of their normal intended use.
8/10/2021 UPDATE
After 8 weeks we have finally received additional information regarding the Phillips/Respironics CPAP and BiPAP recall. Phillips is planning to start shipping their first wave of replacement CPAP devices within the next 7 business days. We have not yet been notified as to who will be receiving them or how long it will take to mitigate all the affected devices. However, if you are one of the individuals who will be receiving a device in the first wave of replacement units, you will be notified directly by Phillips and given additional information on how to complete the process. Philips will have multiple waves of replacements that will happen over time and in each case you will be contacted directly by Philips with instructions on what to do.
Corner Home Medical (CHM) will be providing weekly updates on this site, providing the most current information available. There are several factors that have prolonged this recall process and are creating difficulties for everyone involved. First, there is currently a global shortage of CPAP devices. Prior to the recall being announced, all manufacturers started experiencing issues acquiring key components to produce new devices. This resulted in all providers being put on an allocation status. Meaning that no company can order more devices than their historical purchase history. Second, the FDA has yet to approve the mitigation plan to repair or refurbish current Phillips devices affected by the recall. The Durable Medical Equipment community (suppliers like CHM), physicians, device manufacturers, and Insurance companies have been communicating extensively, working together to take care of as many individuals as possible. Please visit this site weekly as this is where we will be posting any updates and new information. Thank you for your patience and continued support.
Jesse Neumann, Corner Home Medical President
ON 6/14/2021 PHILLIPS RESPIRONICS ISSUED A RECALL ON CPAP AND BIPAP DEVICES, MANDATING THAT PATIENTS MUST WORK DIRECTLY WITH PHILLIPS RESPIRONICS FOR REPAIR OR REPLACEMENT OF RECALLED DEVICES.
Unfortunately, Corner Home Medical is unable to replace your device as Phillips Respironics is not sending any units to DME suppliers. We have been instructed by Phillips Respironics to follow the process below:
Immediate Actions to be taken by You, the User:
- Register your device on the recall website www.philips.com/SRC-update
a. 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.
b. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
OR
- Call 1-877-907-7508 if you cannot visit the website.
If your device is more than 5 years old, contact your physician to get new prescription for a new replacement device. If you are unsure please feel free to contact us via our website with your insurance and contact information and we can check with your insurance company.
