Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/15/2017
Class lI:
PRODUCT
Merge Cardio software
Recall Number Z-1403-2017
REASON
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
110 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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