Reported Mar 29, 2017 · Terminated
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer,…
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 a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data
- Lot codes and dates
Versions 9.09.0.19.0.29.0.39.0.49.0.59.0.69.0.7and 9.0.8
- Amount recalled
- 89 sites potentially have the affected software
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
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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