Device product
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Z-1640-2022
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 90605
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1640-2022
Official wording
Reason: There are 7 reported software anomalies that may affect use of the device.
Code information: VITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568
Distribution pattern: International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
Derived failure modes
-
Device software or design
software anomalies