Respironics Recalls DreamStation Ventilators

Philips Respironics is recalling (Class 1) certain DreamStation auto continuous positive airway pressure (CPAP) and auto bilevel positive airway pressure (BiPAP) devices due to a programming 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,” a recall notice says. To date, it says there have been three reported injuries associated with the issue.

 The ventilators are used nightly at home or in clinical settings to treat obstructive sleep apnea. The affected devices were reworked as part of an earlier foam-related remediation effort and may have been incorrectly configured before distribution.