FDA designates Philips Respironics DreamStation recall as class I

Key takeaways:

• The FDA designated the recall of Philips Respironics DreamStation devices as class I.
• The devices are used in both homes and health care settings to help keep breathing at a regular rhythm.

The FDA has designated Philips Respironics’ recall of DreamStation devices as a class I recall, the most serious kind.

With the ability to provide both bilevel positive airway pressure and continuous positive airway pressure support, the DreamStation devices help keep breathing at a regular rhythm. The devices are used in both homes and health care settings.

The devices were recalled occurred because some were assigned serial numbers that were either incorrect or duplicates during the initial programming, which can cause therapy to be delivered using the wrong prescription or not be delivered at all, according to an FDA alert. The user would have no indication that the DreamStation is not working the way it is intended, and therapy failure could lead to heart failure, respiratory failure, serious injury and death.

The recall is for 1,088 reworked DreamStations that were also recalled in June 2021, according to the alert. The affected units were distributed from December 2021 to October 2022.

While there are currently no reported injuries or deaths, Philips has received 43 complaints about the issue.

Phillips sent users an Important Product Notice on Feb. 10, saying that they should cross-check the serial number of their devices against the serial numbers noted to identify affected products and continue to use their current device until they receive a replacement, or a provider makes pressure changes on the current device.