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

PRODUCT

Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-1180-2017

REASON
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment..

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/17/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 sites have the potentially affected version

DISTRIBUTION
US Distribution was made to medical facilities in AL, IN, MI, PA and WI.

___________________________________