Device product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Z-2228-2025
Product summary
- Event
- Event 97191
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2228-2025
Official wording
Reason: Devices may possess a programming error resulting in an incorrect device configuration.
Code information: Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
programming error