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Recall Observatory FDA recall evidence

Device product

Merge OrthoPACS software.

Z-2620-2017

May 24, 2017

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 77265
Status
Terminated
Classification
Class II
Quantity
98 sites potentially have the affected versions
Official record key
device-enforcement:Z-2620-2017

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 6.6, 6.6.1, and 6.6.2

Distribution pattern: Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.

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.