Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/10/2016
Class lI:
PRODUCT
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Recall Number Z-2303-2016
REASON
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. Hartland, WI on 1/30/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
208 sites
DISTRIBUTION
US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
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