DreamStation Auto CPAP. Non-Continuous Ventilator.
FDA device recall Z-2227-2025 · posted 2025-08-08 · Open, Classified
Recall details
- Recalling firm
- Philips Respironics, Inc.
- Reason for recall
- Devices may possess a programming error resulting in an incorrect device configuration.
- Action taken
- Consignees were contacted by phone from 6/30/25 to 7/02/25 to facilitate provision of a replacement device. Additionally, a "Medical Device Recall Field Safety Notice" dated 6/6/2025 was sent to consignees instructing them to continue using their affected device until Philips Respironics can ship them a replacement. DMEs are to share the notice with those who need to be aware within their organization and to organizations where devices were transferred. If a consignee received the written notice but not a phone call from Philips Respironics, they are to call 1-877-387-3311 or email PatientSupport@philips.com. Consignees with any questions can contact Philips Respironics at 1-800-345-6443 (prompts 4, 5).
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BZD
- Quantity affected
- 57 units
- Distribution
- Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.
- Date initiated
- 2025-06-30
- Date posted
- 2025-08-08
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REMSTAR AUTO A-FLEX HT (K131982) | Respironics, Inc. | 2013-10-18 |