Company: Merge Healthcare, Inc.
Date of Enforcement Report 7/20/2016
Class lI:
PRODUCT
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Recall Number Z-2159-2016
REASON
Potential data loss occurs as a result of product archiving not working properly.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 1/31/16 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
48 sites have affected software
DISTRIBUTION
Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/militar y/foreign distribution.
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