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Recall Observatory FDA recall evidence

Device 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.

Z-2363-2016

February 05, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 74776
Status
Terminated
Classification
Class II
Quantity
49 sites potentially have the affected versions
Official record key
device-enforcement:Z-2363-2016

Official wording

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.

Code information: Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1

Distribution pattern: Worldwide Distribution -- USA and Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.