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Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes

The U.S. Food and Drug Administration (FDA) is aware that Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programing error introduced during rework by a supplier, which may result in incorrect therapy modes (e.g., BiPAP configured as CPAP), limited pressure, unavailable features, or improper sensor/humidifier function.

Use of the affected devices may cause serious health consequences including hypoventilation, disrupted sleep, skin or airway burns, and ineffective treatment of sleep apnea, which could worsen comorbidities.

There have been three reported injuries and no reports of death.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Questions?

Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-877-387-3311 or PatientSupport@philips.com.