The U.S. Food and Drug Administration on Friday announced the recall of certain Philips Respironics devices designed to help people with breathing conditions keep breathing at a regular rhythm.
The recall is for some Philips Respironics DreamStation1 (Uno Remediated Devices), according to the FDA, which
identified it as a Class I recall, the most serious type.
“Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming,” the recall notice says. “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 product models affected are: REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM - RECRT
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Recalls
For serial numbers, go to the Medical Device Recall Database
There are 1,088 devices recalled in the U.S., the FDA said, adding that there had been 43 complaints about the issue, with no reported injuries or deaths.
How to Learn More
For more information, call: 1-(877)-387-3311; email: patientsupport@philips.com; or go to Philips Information for Patients.
