Company: Merge Healthcare, Inc.
Date of Enforcement Report 2/152017
Class lI:

PRODUCT

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-1176-2017

REASON
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4//2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
29 sites have the potentially affected software

DISTRIBUTION
Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.

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