Recall Z-2229-2025 ยท BZD Ventilator, Non-Continuous (Respirator)
Philips Respironics, Inc.
DreamStation Auto. Non-Continuous Ventilator.
| Date | Aug 8, 2025 (initiated Jun 30, 2025) |
| Status | Open, Classified |
| Reason | Devices may possess a programming error resulting in an incorrect device configuration. |
| Root cause | Process control |
| Action | 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 PatientSupp |
| Quantity | 28 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131982 | REMSTAR AUTO A-FLEX HT Respironics, Inc., Oct 18, 2013 |