Reported Feb 15, 2017 · Terminated
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
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 RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Lot codes and dates
- Version V8.30.7.8
- Amount recalled
- 8 sites have the potentially affected version
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The values provided from the Pixel Value tool do not appear to be correct, 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.
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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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