Reported Sep 28, 2016 · Terminated
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a…
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 Cardio software
- Product UsageMerge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system
- Lot codes and dates
- Version 10.1
- Amount recalled
- 42 sites potentially 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
Why it was recalled
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
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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