FDA Identifies Class I Recall on Philips CPAP and BiPAP Machines

On April 7, 2023, the FDA identified a Class I recall on the Philips Respironics CPAP and BiPAP machines due to inaccurate or insufficient therapy. The devices, intended for treating sleep apnea, had a previous recall in September 2022 when flaws were found in the masks.

According to the FDA information sheet, the recalled devices have been issued incorrect or duplicate serial numbers. Some devices may be unable to deliver therapy altogether, leading to potentially fatal breathing complications for the patient.

Although some devices may deliver some therapy, the incorrect serial number or a duplicate serial number may have impacted the device’s programming, leading to incorrect therapy delivery from a wrong prescription or return to the default factory settings.

The impacts of this recall are undetectable to the user as the device does not notify them of these complications. Left untreated — or treated inappropriately — sleep apnea can cause respiratory failure, heart failure, injury, or death.

While no injuries or fatalities have been identified yet, Philips has been notified of 43 incidences where the device failed or worked incorrectly. Based on the severe risks associated with the devices working incorrectly, the company, with the support of the FDA, has issued a recall on multiple devices.

The recall applies to 1,088 medical devices distributed between December 1, 2021, and October 31, 2022. The Philips Respironics DreamStation1 device recall includes the following models: REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto CPAP, DOM RECRT.

Both machines are widely distributed for patients diagnosed with sleep apnea to assist in breathing throughout the night. The CPAP machine provides a continuous air stream for people with obstructive sleep apnea. The BiPAP machines provide varying pressure depending on the user’s breathing pattern.

The serial numbers of the affected devices are listed on the FDA Medical Device Recall Database. Patients or caretakers who believe their device is affected should compare the serial number with those in the database.

In the recall notice, Philips recommends that users continue to use the current device until a replacement or change has been made. Additionally, they may contact their provider and request a manual device reset. Additionally, any reports of complications should be sent to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.