Breaking: FDA Authorizes Philips to Fix PAP Devices Through Class I Recall
Last updated: March 2022
If the CPAP or Bilevel PAP machine you use was recalled this June and you have been waiting in frustration for a replacement, there is some potentially good news on the horizon.
On September 1, 2021, the U.S. Food and Drug Administration (FDA) authorized the manufacturer of the recalled machines, Philips, to begin the replacement of foam parts in certain sleep breathing devices as soon as this month. This is a U.S.-only recall notification.1
The FDA has classified this update on the original June 14, 2021 recall as a "Class I recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."2
Sen. Richard Blumenthal (D-CT) recently launched an inquiry into Philips' "timeline for submitting a mitigation plan with sufficient evidence to [the Food and Drug Administration] for authorization of a permanent solution." This follows a number of recent filings of class-action lawsuits against the company, suggesting Philips unreasonably delayed their recall last spring. This likely spurred the company to take new action.3
The urgency to repair as many as 4 million sleep apnea therapeutic devices is also likely due to the ongoing global shortage of computer chips. This reality has made it difficult for Philips' biggest manufacturing rival, ResMed, to build enough new machines to fill in the gap created by the recall. It is estimated that the microchip shortage may continue well into 2022, far too long for the millions who need their sleep apnea therapy now.4
About the original recall
The polyester-based polyurethane (PE-PUR) foam, built into the machines as a kind of sound barrier, was recently found to disintegrate in these machines, leading to serious injury risks – possibly life-threatening – for users who might inhale these particles or related chemicals caused by the breakdown of the foam while using this therapy.5
Problems with degrading foam have been linked to both high heat and humidity environments and the unapproved use of ozone or other PAP cleaning devices.5
The devices recalled earlier this year include the following, manufactured between 2009 and April 25, 2021:5
- DreamStation ASV
- DreamStation ST, AVAPS
- SystemOne ASV4
- C-Series ASV
- C-Series S/T and AVAPS
- OmniLab Advanced+
- SystemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
If you want a repair, register with Philips now
If you still have one of the recalled devices, it will need to be registered with Philips as soon as possible if you want it replaced or repaired. Register your device here.6
Philips offers this statement: "The structural solution of the component quality issue is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam," adding that "the replacement of certain affected devices is already underway."7
Who will manage your repair or replacement?
Who will manage the timeline and status of your particular repair or replacement? It depends upon where you acquired your machine.
A company spokesperson has suggested that if your machine was provided to you through a durable medical equipment (DME) provider, the DME will manage its replacement process and provide users with a timeline and status for their particular machine.7
However, if a person registers their product independently of their DME, Philips and the DME will consult to determine which organization will manage the replacement process. If the DME authorizes Philips to replace your equipment, Philips will be in contact with you regarding the timeline and status.7
What is the repair timeline?
It is unclear how long it will take for people to see their machines repaired. But, as PAP users may already be aware, visiting the various CPAP sales outlets shows that most devices not under recall remain in very low inventory or are completely sold out.
CPAPNation.com, as one example, has posted the following announcement on its website: "Due to a global supply chain shortage of CPAP devices, limited machines are available; however, we are committed to updating our stock on a daily basis & notifying our subscribers of any changes."8
The replacement of the prior foam product with a newer, safer option that does not deteriorate will likely still be a swifter remedy than waiting for new machines to be built.
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