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Merge Healthcare, Inc. recalls Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Recalled March 29, 2017 · FDA recall Z-1415-2017 · Merge Healthcare
Hazard
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. · FDA Class II
Units
17 sites potentially have the affected versions
Sold at
US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
Description
A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.
Product
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →