Company: Novarad Corporation
Date of Enforcement Report 7/20/2016
Class lI:
PRODUCT
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS).
Recall Number Z-2151-2016
REASON
Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
RECALLING FIRM/MANUFACTURER
Novarad Corporation , American Fork, UT on 5/9/2013 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2695
DISTRIBUTION
Nationwide and internationally. No Canadian distribution
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