Recall Z-2229-2025
Philips Respironics, Inc. · initiated June 30, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
DreamStation Auto. Non-Continuous Ventilator.
Codes / lots: Model No. UFRX500S14; UDI: 606959069824; Serial No. J19093383C0FD, J195817171415, J195967969739, J1999161223D4, J208714453211, J21638786344A, J216718740A24, J22792026797C, J23016752559D, J23025544A4CA, J235207601E36, J236974697023, J24378890CB57, J24404277EDBB, J251606314EAA, J255220797791, J25755126C4A9, J262274772766, J26263484C9C9, J26377226BCF1, J26525214B253, J2661985603DE, J26673715FBD4, J27099876ED61, J272180530173, J27467764497E, J305016887150, J30708300FB50.
Reason for recall
Devices may possess a programming error resulting in an incorrect device configuration.
FDA-determined cause: Process control
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).
Details
- Recall number
- Z-2229-2025
- Initiated
- June 30, 2025
- Posted by FDA
- August 8, 2025
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- 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.
- Recalling firm
- Philips Respironics, Inc., Murrysville, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2227-2025 Class I | DreamStation Auto CPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration. | 06/30/2025Open, Classified |
| Z-2228-2025 Class I | DreamStation Auto BiPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration. | 06/30/2025Open, Classified |