FDA: Class I recall of certain Philips Respironics reworked DreamStation CPAP, BiPAP machines

Editor's Note

The Food and Drug Administration, on April 7, identified the recall by Philips Respironics of certain reworked DreamStation continuous positive airway pressure (CPAP) and bileveled positive airway pressure (BiPAP) machines as Class I, the most serious. These machines also were recalled in June 2021.

The recall was initiated because some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered with the wrong prescription or factory default settings, and it may fail to deliver therapy at all. There is no warning or indication that the machine is not working the way it was intended or prescribed.

The company has received 43 complaints. There are no reported injuries or deaths.

Distribution dates were December 1, 2021, to October 31, 2022.