Reported Feb 1, 2017 · Terminated

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a…

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

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Lot codes and dates: Versions 6.10
6.10.1
6.10.2
6.10.3
7.10
7.20
7.20.1
8.10.0
8.20
9.10.0
9.20
9.20.2
9.20.3
9.30
9.40
9.40.1
9.40.2
and 9.40.3
Amount recalled: 242 sites potentially have the affected versions

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

This product could cause temporary or reversible health problems — stop using it.

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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54 in total.