Class 2 Device Recall NovaPACS

• Date Initiated by Firm: May 09, 2013
• Create Date: July 11, 2016
• Recall Status: Terminated 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: 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