Philips announces recall for reworked DreamStation CPAP, BiPAP machines due to defect

Philips CPAP recall overview: 

• Who: Philips has recalled 1,088 of its Philips Respironics DreamStation1 (Uno Remediated Devices) in the US. 
• Why: The recall was initiated over concerns the devices were “assigned incorrect or duplicate serial numbers” during their initial programming. 
• Where: Nationwide. 

Philips has recalled 1,088 of its Philips Respironics DreamStation1 (Uno Remediated Devices) in the US over concerns some were “assigned incorrect or duplicate serial numbers during initial programming.” 

The recall includes Philips REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, REP DreamStation Auto CPAP, and DOM – RECRT devices, according to a recall published by the FDA on April 7. 

Philips is concerned the apparent incorrect or duplicate serial numbers assigned to the recalled devices could lead “therapy to be delivered using the wrong prescription or factory default settings” or “fail to deliver any therapy at all.” 

“There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed,” the Philips recall states. 

Philips said it has received a total of 43 complaints about the issue, however it said it has not received any reports of injury or death in connection with the recall. 

Philips sent ‘Important Product Notice’ to impacted customers, patients in February 

Impacted customers and patients were sent an “Important Product Notice” on Feb. 10 that recommended they locate and verify the serial number on their devices, according to the Philips recall. 

Philips also advised customers and patients to continue using their current devices either until a replacement device could be received or their provider was able to conduct a pressure change on their current device. 

A class action lawsuit was filed against Philips last year over claims the company knew that its CPAP devices contained polyester-based polyurethane sound abatement foam allegedly prone to degrading and causing adverse health effects. 

Are you affected by the Philips recall? Let us know in the comments! 

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