Reported Jan 25, 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
9.09.0.19.0.29.0.39.0.49.0.59.0.69.0.79.0.89.0.910.010.0.110.110.1.1and 10.1.2
- Versions
- Amount recalled
- 188 sites potentially have the effected versions
Where it was sold
- Nationwide
Why it was recalled
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
This product could cause temporary or reversible health problems — stop using it.
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