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Recall Observatory FDA recall evidence

Device product

Merge PACS software. The firm name on the label is Merge Healthcare.

Z-1431-2017

April 04, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76594
Status
Terminated
Classification
Class II
Quantity
248 sites potentially have the affected versions
Official record key
device-enforcement:Z-1431-2017

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 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, and 7.0.1

Distribution pattern: USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or 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.