Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/31/2016
Class lI:
PRODUCT
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-2627-2016
REASON
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport..
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 8/23/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
25 sites have the affected version
DISTRIBUTION
Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.
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