Philips Respironics, Inc.: DreamStation Auto. Non-Continuous Ventilator.

Hazard

Devices may possess a programming error resulting in an incorrect device configuration.

Details from the source

Reason for recall: Devices may possess a programming error resulting in an incorrect device configuration. 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. Quantity: 28 units Lot/code info: 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.

UPC codes

606959069824

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.