Reported Jun 21, 2017 · Terminated
Merge PACS 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 PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Lot codes and dates
Versions 7.0.2.17.0.2.27.0.2.37.0.2.3 P1and 7.0.2.3 P2
- Amount recalled
- 47 sites potentially have the affected versions
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
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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