Recall Z-2151-2016 ยท LLZ System, Image Processing, Radiological
Novarad Corporation
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
| Date | May 9, 2013 |
| Status | Terminated |
| Reason | Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. |
| Root 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 | 2695 |
| Distribution | Worldwide distribution including US nationwide. No Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063153 | NOVAPACS Novarad Corp., Dec 7, 2006 |