Device product
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Z-2095-2025
Product summary
- Event
- Event 97072
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 14 units
- Official record key
device-enforcement:Z-2095-2025
Official wording
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Code information: UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523
Distribution pattern: US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.
Derived failure modes
-
Device software or design
incorrect version of software