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Recall Observatory FDA recall evidence

Device 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.

Z-2303-2016

January 30, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 74651
Status
Terminated
Classification
Class II
Quantity
208 sites have the affected versions
Official record key
device-enforcement:Z-2303-2016

Official wording

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.

Code information: Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.