Philips recalls certain reworked devices
By HME News Staff
Updated 10:28 AM CDT, Fri April 7, 2023
WASHINGTON – The U.S. Food & Drug Administration on April 7 announced Philips has recalled certain reworked DreamStation CPAP, BiPAP devices for the risk they may deliver inaccurate or insufficient therapy.
The company is recalling 1,088 devices that were distributed between Dec. 1, 2021, and Oct. 31, 2022.
“Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming,” the FDA states. “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.”
The FDA says Philips has received 43 complaints related to this issue.
The company, which initiated the recall on Feb. 10, has sent affected provider customers and patients an “Important Product Notice” with recommendations. For providers, it says a replacement product will be provided for exchange of affected devices.
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