Reported Aug 10, 2016 · Terminated
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display…
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. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
- Lot codes and dates
- Versions
V6.0 MR4 CU 1-116.1.06.1.16.1.1.16.1.26.1.36.1.3.16.2.06.2.16.2.26.2.2.1and 6.2.3
- Versions
- Amount recalled
- 109 sites have the affected versions
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
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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