Reported Sep 7, 2016 · Terminated
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means 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?
- RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
- Lot codes and dates
Versions V8.30.68.30.6.18.30.6.2and 8.30.6.3
- Amount recalled
- 96 sites potentially have the affected versions for both products
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
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
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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