Reported Aug 17, 2016 · Terminated
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to…
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. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
- Lot codes and dates
- VersionsV6.0.2.0 MR2 and earlier
- Amount recalled
- 93 sites have the affected version
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
- MN
Why it was recalled
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
This product could cause temporary or reversible health problems — stop using it.
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