Merge PACS software imaging Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/17/2016
Class lI:

PRODUCT

Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Recall Number Z-2363-2016

REASON
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.p>

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 2/5/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
49 sites potentially have the affected versions

DISTRIBUTION
USA and Australia

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