Company: Merge Healthcare, Inc.
Date of Enforcement Report 1/11/2017
Class lI:
PRODUCT
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Recall Number Z-0939-2017
REASON
The software fails to associate to the correct MG image if there are two images for the same view.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 10/15/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9 sites potentially have the effected versions
DISTRIBUTION
Distribution was made to medical facilities located in MT, CA, PA, and TX.
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