Device product
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Z-2059-2018
Product summary
- Event
- Event 79968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 analyzers
- Official record key
device-enforcement:Z-2059-2018
Official wording
Reason: Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Code information: GTIN 05055273206104. All serial numbers.
Distribution pattern: US Distribution including Puerto Rico and the state of : West Virginia.
Derived failure modes
-
Device software or design
software could