Device product
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Z-1223-2022
Product summary
- Event
- Event 90163
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1223-2022
Official wording
Reason: Software anomaly was identified.
Code information: Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Derived failure modes
-
Device software or design
Software anomaly