Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices, according to a September 12th FDA alert.
The recall is due to a programing error introduced during rework by a supplier, which may result in incorrect therapy modes (eg, BiPAP configured as CPAP), limited pressure, unavailable features, or improper sensor/humidifier function, the FDA reports.
DreamStation Auto CPAP and Auto BiPAP devices are used nightly at home or in clinical settings to treat obstructive sleep apnea, the FDA says. The affected devices were reworked as part of an earlier foam-related remediation effort and may have been incorrectly configured before distribution.
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, according to the FDA.
There have been three reported injuries and no reports of death, the FDA reports.
Affected Product
| Product Description | Model Number | UDI-DI |
|---|---|---|
| DreamStation Auto CPAP | UDSX500S11F | 00606959423314 |
| DreamStation Auto BiPAP | UDSX700S11F | 00606959423338 |
| DreamStation Auto CPAP | UFRX500S14 | 00606959455045 |
FDA Recommendations
On June 6, 2025, Philips Respironics sent all affected customers an Urgent Medical Device Recall Letter recommending the following actions:
- Continue using the device until a replacement is delivered.
- Contact Philips at 1-877-387-3311 or [email protected] if you received the letter but have not been contacted.
- Return affected devices using the included instructions and prepaid label when the replacement arrives.
- Be aware that Philips is calling affected patients and suppliers and sending replacement devices with return instructions.
More information is available on the FDA website.
