NovaPACS Diagnostic Viewer versions 8 — Class II medical device recall Z-1613-2016
Terminated recall by Novarad Corporation, reported 2016-05-18, distributed nationwide. The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
| Recall number | Z-1613-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novarad Corporation, American Fork, UT, United States |
| Recall initiated | 2015-11-16 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2016-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,386 |
Product
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Reason for recall
The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1613-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.