Merge Healthcare, Inc. recalls Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a card

Recalled February 1, 2017 · FDA recall Z-1091-2017 · Merge Healthcare

Hazard

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. · FDA Class II

Units

242 sites potentially have the affected versions

Sold at

Nationwide Distribution

Description

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.

Product

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

Manufacturer(s)

Merge Healthcare, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →