Device product
VIDAS 3 software v. 1.1.4
Z-1200-2017
Product summary
- Firm
- BioMerieux SA
- Event
- Event 76281
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1161 units
- Official record key
device-enforcement:Z-1200-2017
Official wording
Reason: During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field.
Code information: REF: #412590, Lot: Software version 1.1.4
Distribution pattern: U.S.
Derived failure modes
-
Device software or design
software version 1.2, some anomalies