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Recall Observatory FDA recall evidence

Device product

Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

Z-2601-2017

May 24, 2017

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 77271
Status
Terminated
Classification
Class II
Quantity
160 sites potentially have the affected versions
Official record key
device-enforcement:Z-2601-2017

Official wording

Reason: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

Code information: Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.