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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 May 09, 2013
Create Date July 11, 2016
Recall Status1 Terminated 3 on December 01, 2016
Recall Number Z-2151-2016
Recall Event ID 74556
510(K)Number K063153  
Product Classification System, image processing, radiological - Product Code LLZ
Product NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Code Information All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0
Recalling Firm/
Manufacturer		 Novarad Corporation
752 E 1180 S Ste 200
American Fork UT 84003-3561
For Additional Information Contact Doug Merrill
801-642-1001
Manufacturer Reason
for Recall		 Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
FDA Determined
Cause 2		 Software design
Action Consignees were notified on 05/09/13 via letter and email to upgrade software and to turn off streaming function.
Quantity in Commerce 2695
Distribution Worldwide distribution including US nationwide. No Canadian distribution.
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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