Merge Healthcare, Inc. recalls Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
- Recall date
- April 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1498-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
Why it was recalled
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
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