Company: Merge Healthcare, Inc.
Date of Enforcement Report 4/26/2017
Class lI:
PRODUCT
Merge Eye Station and Merge Eye Care PACS
Recall Number Z-1828-2017
REASON
During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
1627 sites potentially have the affected versions
DISTRIBUTION
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
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