Cl II NovaPACS Diagnostic Viewer

Company: Novarad Corporation
Date of Enforcement Report 5/18/2016
Class lI:

PRODUCT

NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Recall Number Z-1613-2016

REASON
IThe SUV values that are being calculated in the PET/CT fusion tool are incorrect.

RECALLING FIRM/MANUFACTURER
Novarad Corporation, American fork, UT on 11/16/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,386

DISTRIBUTION
Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.