Z-2151-2016 Class II Terminated

Recalled by Novarad Corporation — American Fork, UT

Recall Details

Product Type
Devices
Report Date
July 20, 2016
Initiation Date
May 9, 2013
Termination Date
December 1, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2695

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide distribution including US nationwide. No Canadian distribution.

Code Information

All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0