“Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy” – FDA.gov
Reason for Recall
Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming. This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may 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.
Incorrect therapy or therapy failure may lead several health conditions such as respiratory failure, heart failure, serious injury, and death.
Philips has received 43 complaints about this issue. There are currently no reported injuries or deaths.