Philips Recalls Certain Reworked DreamStation CPAP, BiPAP Machines

Philips Respironics is recalling some reworked DreamStations because some of the devices were assigned incorrect or duplicate serial numbers during initial programming. The U.S. Food and Drug Administration (FDA) has identified Philips’ February 10 recall as Class I.
 
The duplication can cause the therapy delivered using the incorrect prescription or factory default settings. In fact, it may fail to deliver any therapy at all and there’s no warning or indication to the user the DreamStation isn’t working the way the doctor intended or prescribed.
 
The recall covers certain reworked DreamStations that were also recalled in June 2021.
 
Philips Respironics DreamStation devices assist in keeping breathing at a regular rhythm for those with breathing conditions. Used in both hospitals/healthcare settings and the home, DreamStation can offer both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) support.
 
Receiving incorrect therapy or experiencing therapy failure can lead to conditions like respiratory failure, heart failure, serious injury, or death. To date, Philips has received 43 complaints concerning this issue, with no reported injuries or deaths.
 
Philips urged users to identify affected products by locating the device’s serial number and verify it against serial numbers noted in their letter.

The company also recommended continuing to use their current device until a replacement is received or until pressure changes are made by the user’s provider on the current device.
 
Users were also advised to contact their provider about getting a manual reset of pressure either remotely or in person.
 
The company also had a recall of certain reworked Trilogy and Garbin Plus ventilators this year, which were also subject to the June 2021 recall.