FDA Device recall Z-2956-2020
NovaPACS Diagnostic Viewer
- FDA Device
- Class II
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class II recall of NovaPACS Diagnostic Viewer by Novarad, citing the firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2956-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-10 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Novarad |
| Distribution | US |
Product
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
Reason
The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.
Identifiers
| code_info | NovaPACS versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2956-2020%22
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