Device product
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
Z-1050-2013
Product summary
- Event
- Event 64386
- Status
- Terminated
- Classification
- Class III
- Quantity
- 180 units
- Official record key
device-enforcement:Z-1050-2013
Official wording
Reason: Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Code information: All serial numbers
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.