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Merge Healthcare, Inc. recalls Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Recalled March 29, 2017 · FDA recall Z-1498-2017 · Merge Healthcare
Hazard
System locks up which may result in potential patient injury or delay in diagnosis or treatment. · FDA Class II
Units
78 sites potentially have the affected accessory
Sold at
Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
Description
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Product
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →