Reported Jun 28, 2017 · Terminated
Merge OrthoPACS 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 OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Lot codes and dates
Versions 6.66.6.16.6.26.6.2.1and 6.6.2.2
- Amount recalled
- 160 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
Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
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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