Reported Mar 29, 2017 · Terminated
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
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 with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
- Lot codes and dates
Versions 8.309.09.0.19.0.29.0.39.0.49.0.59.0.69.0.79.0.810.010.0.1and 10.1 with Issuer of Patient ID (IPID)
- Amount recalled
- 16 sites were originally identified as potentially having the affected versions
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
Why it was recalled
For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.
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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