Philips Respironics is recalling sure DreamStation Auto CPAP and Auto BiPAP gadgets, in accordance with a September twelfth FDA alert.
The recall is because of a programing error launched throughout rework by a provider, which can lead to incorrect remedy modes (eg, BiPAP configured as CPAP), restricted stress, unavailable options, or improper sensor/humidifier operate, the FDA reviews.
DreamStation Auto CPAP and Auto BiPAP gadgets are used nightly at dwelling or in scientific settings to deal with obstructive sleep apnea, the FDA says. The affected gadgets had been reworked as a part of an earlier foam-related remediation effort and will have been incorrectly configured earlier than distribution.
Use of the affected gadgets could trigger critical well being penalties together with hypoventilation, disrupted sleep, pores and skin or airway burns, and ineffective remedy of sleep apnea, which might worsen comorbidities, in accordance with the FDA.
There have been three reported accidents and no reviews of loss of life, the FDA reviews.
Affected Product
| Product Description | Mannequin Quantity | UDI-DI |
|---|---|---|
| DreamStation Auto CPAP | UDSX500S11F | 00606959423314 |
| DreamStation Auto BiPAP | UDSX700S11F | 00606959423338 |
| DreamStation Auto CPAP | UFRX500S14 | 00606959455045 |
FDA Suggestions
On June 6, 2025, Philips Respironics despatched all affected prospects an Pressing Medical System Recall Letter recommending the next actions:
- Proceed utilizing the gadget till a alternative is delivered.
- Contact Philips at 1-877-387-3311 or [email protected] for those who acquired the letter however haven’t been contacted.
- Return affected gadgets utilizing the included directions and pay as you go label when the alternative arrives.
- Bear in mind that Philips is asking affected sufferers and suppliers and sending alternative gadgets with return directions.
Extra info is obtainable on the FDA web site.
