Recall Z-1613-2016 ยท LLZ System, Image Processing, Radiological
Novarad Corporation
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
| Date | May 6, 2016 (initiated Nov 16, 2015) |
| Status | Terminated |
| Reason | The SUV values that are being calculated in the PET/CT fusion tool are incorrect. |
| Root cause | Software design |
| Action | Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software. |
| Quantity | 2,386 |
| Distribution | Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132853 | NOVAPACS Novarad Corp., Oct 30, 2014 |