Class II — Novarad Corporation
| Recalling firm | NOVARAD CORP. |
|---|---|
| Registered facility | NOVARAD CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The SUV values that are being calculated in the PET/CT fusion tool are incorrect. |
| Product | NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation |
| Quantity | 2,386 |
| Distribution | Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military. |
| Initiated | 2015-11-16 |
| Classified | 2016-05-06 |
| Terminated | 2016-08-17 |
| Recall number | Z-1613-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Novarad Corporation (Z-1613-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73977/
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