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
|