Reported Oct 26, 2016 · Terminated
Fusion Workstation.; Indicated for the transmission and review of radiological images.
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?
- Fusion Workstation.; Indicated for the transmission and review of radiological images.
- Lot codes and dates
Versions V3.0.2 P33.023.13.23.3and 3.3.1
- Amount recalled
- 13 sites potentially hae the 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
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
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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