Sleep and home respiratory care products provider Philips Respironics (Philips) is recalling certain reworked DreamStation devices due to the risk of delivering inaccurate or insufficient therapy.
The company began the recall of 1,088 devices in the US in February this year.
Developed to help people with respiratory problems maintain breathing at a regular rhythm, the DreamStation device offers both continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) support.
The recalled product models include REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM – RECRT.
Some of the devices that were earlier recalled in June 2021 and reworked might have been assigned incorrect or duplicate serial numbers during programming.
The duplication may result in the delivery of therapy using the wrong prescription or factory default settings.
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Furthermore, it is also possible that the device may not deliver any therapy at all.
The US Food and Drug Administration has placed the recall under Class I recall category, which is the most serious type and such faulty devices have the potential to cause serious injuries or death.
In a statement, the FDA said: “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 to several health conditions, such as respiratory failure, heart failure, serious injury, and death.”
Philips has to date received 43 complaints regarding the issue and no injuries or deaths have been attributed to it.
The affected products can be identified by comparing the serial number of the device with the serial numbers noted in the recall letter, stated the FDA.