| 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 |
| FEI Number |
1000117423
|
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
|
|---|
