Reported Dec 21, 2016 · Terminated
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive…
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. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems 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 V10.1 and 10.1.1
- Amount recalled
- 116 sites potentially have the effected versions
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
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
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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