Recall Issued for Phillips DreamStation CPAP, BIPAP Machines

The Food and Drug Administration (FDA) issued a recall for certain models of DreamStation1 devices (Phillips Respironics, Murrysville, PA) distributed in the United States from December 1, 2021 through October 31, 2022. The recall affects an estimated 1,088 devices and has been designated by the FDA as a Class I recall---the most serious recall type, indicating a potential for serious injury or death.

The Dreamstation devices provide continuous positive airway pressure (CPAP) and bilateral positive airway pressure (BiPAP) to help people with breathing conditions, including in those diagnosed with obstructive sleep apnea. According to details provided in the recall notification, some of the devices were assigned duplicate or incorrect serial numbers during initial programming, which may result in the device not providing any therapy or providing therapy using the wrong prescription or default factory settings. A full list of models affected and specific serial numbers may be found on the FDA’s website.

Philips indicates that it will provide replacement devices for those customers affected by this recall and advises customers to contact the company directly with questions by either telephone or email as follows:

• Phone: 1-800-345-6443, prompts 4, 5
• Email: respironics.clinical@philips.com