Device product
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Z-1498-2017
Product summary
- Event
- Event 76312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78 sites potentially have the affected accessory
- Official record key
device-enforcement:Z-1498-2017
Official wording
Reason: System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Code information: Versions 1.1.2 and 1.1.3
Distribution pattern: Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
Derived failure modes
-
Unknown
System locks up which may result in potential patient injury or delay in diagnosis or treatment.