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Recall Observatory FDA recall evidence

Device product

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

Z-2590-2017

May 08, 2017

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 77248
Status
Terminated
Classification
Class II
Quantity
47 sites potentially have the affected versions
Official record key
device-enforcement:Z-2590-2017

Official wording

Reason: Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

Code information: Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.