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U.S. Department of Health and Human Services

Class 2 Device Recall NovaPACS

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  Class 2 Device Recall NovaPACS see related information
Date Initiated by Firm November 16, 2015
Date Posted May 06, 2016
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-1613-2016
Recall Event ID 73977
510(K)Number K132853  
Product Classification System, image processing, radiological - Product Code LLZ
Product NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Code Information Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4
Recalling Firm/
Manufacturer		 Novarad Corporation
752 E 1180 S Ste 200
American Fork UT 84003-3561
For Additional Information Contact Douglas C. Schroeppel
801-642-1001
Manufacturer Reason
for Recall		 The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
FDA Determined
Cause 2		 Software design
Action Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.
Quantity in Commerce 2,386
Distribution Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = NOVARAD CORP.
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