Reported Mar 22, 2017 · Terminated
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays…
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 Hemo software
- Product UsageMerge Hemo is a hemodynamic monitoring system that records and displays physiological data
- Lot codes and dates
Versions 6.106.10.16.10.26.10.37.107.207.20.18.10.08.209.10.09.209.20.29.20.39.309.409.40.19.40.2and 9.40.3
- Amount recalled
- 361 sites potentially have the affected 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
In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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