Reported Mar 15, 2017 · Terminated
DR Systems Unity PACS software, now known as Merge Unity PACS
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?
- DR Systems Unity PACS software, now known as Merge Unity PACS
- Lot codes and dates
- Version 11.0
- Amount recalled
- 9 sites potentially have 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
Reports were missing demographic header information when they were faxed to referring physicians.
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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