Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/14/2016
Class lI:
PRODUCT
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
Recall Number Z-0726-2017
REASON
Cut lines on the image may present horizontally rather than vertically..
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 3/28/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
537 sites potentially have the affected versions
DISTRIBUTION
Nationwide and Internationally
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