Reported Mar 1, 2017 · Terminated
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
- Lot codes and dates
- Merge ESIU
Versions 1.01.1.11.1.2and 1.1.3
- Merge Eye StationAll versions
- Merge Eye Care PACS
Versions 4.14.24.35.0and 5.1
- Merge ESIU
- Amount recalled
- 1,627 sites potentially have the affected versions
Where it was sold
- Nationwide
Why it was recalled
Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
This product could cause temporary or reversible health problems — stop using it.
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