Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/15/2017
Class lI:
PRODUCT
Merge Cardio software using EchoIMS
Recall Number Z-1415-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
17
sites potentially have the affected versions
DISTRIBUTION
US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.
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