Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/22/2017
Class lI:
PRODUCT
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare
Recall Number Z-1470-2017
REASON
The software produced a number of ”do not route” exceptions, which may result in potential patient injury or delay in diagnosis or treatment..
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
187 sites potentially have the affected versions
DISTRIBUTION
USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
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