Class II — Novarad Corporation
| Recalling firm | NOVARAD CORP. |
|---|---|
| Registered facility | NOVARAD CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released. |
| Product | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The… |
| Quantity | 90 |
| Distribution | Worldwide Distribution - US (Nationwide) Canada and other foreign consignees. |
| Initiated | 2016-08-12 |
| Classified | 2016-08-25 |
| Terminated | 2017-02-22 |
| Recall number | Z-2659-2016 |
| 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-2659-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74937/
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