Philips Respironics is recalling certain DreamStation CPAP and BiPAP devices due to a programming error introduced during rework by a supplier.
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices following the discovery of a programming error. The US Food and Drug Administration (FDA) has identified this as a Class I recall.
The error was introduced by a supplier during rework on the devices, which were part of a previous remediation effort related to foam degradation. According to the FDA notice, the programming issue may cause the devices to deliver incorrect therapy modes, such as a BiPAP machine being configured as a CPAP. Other potential malfunctions include limited pressure, unavailable features, or improper function of the sensor or humidifier.
Use of the affected ventilators could lead to serious health consequences, including hypoventilation, disrupted sleep, ineffective treatment of sleep apnea, and skin or airway burns. To date, there have been three reported injuries and no reports of death associated with this issue.
Background and Recommendations for HTM Professionals
The non-continuous ventilators are used to treat obstructive sleep apnea in both home and clinical settings. The affected units were incorrectly configured before being distributed after the earlier rework.
On June 6, 2025, Philips sent an Urgent Medical Device Recall Letter to all affected customers with recommendations. Healthcare technology management professionals and other customers in the US with questions regarding the recall are advised to contact Philips Respironics at 1-877-387-3311.
The FDA encourages healthcare professionals and consumers to report adverse reactions or quality problems experienced with these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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