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Recall Observatory FDA recall evidence

Device product

NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)

Z-2151-2016

May 09, 2013

Class II

Product summary

Firm
Novarad Corporation
Event
Event 74556
Status
Terminated
Classification
Class II
Quantity
2695
Official record key
device-enforcement:Z-2151-2016

Official wording

Reason: Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

Code information: All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0

Distribution pattern: Worldwide distribution including US nationwide. No Canadian distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.