Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/7/2016
Class lI:
PRODUCT
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
Recall Number Z-0664-2017
REASON
Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/28/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
324 sites potentially have the affected version
DISTRIBUTION
Nationwide
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