Reported Mar 29, 2017 · Terminated
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
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). The firm name on the labeling is Merge Healthcare.
- Lot codes and dates
- Versions 1.1.2 and 1.1.3
- Amount recalled
- 78 sites potentially have the affected accessory
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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