FDA Device recall Z-1613-2016
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation by Novarad, citing the SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1613-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-16 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Novarad |
| Distribution | US |
Product
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Reason
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Identifiers
| code_info | Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1613-2016%22
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