18
May
2016

Cl II NovaPACS Diagnostic Viewer

0

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.

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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