NovaPACS Diagnostic Viewer — Class II medical device recall Z-2956-2020
Terminated recall by Novarad Corporation, reported 2020-09-23, distributed nationwide. The firm received a report of an atypical dataset being generated. When using the cross-localization feature a
| Recall number | Z-2956-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novarad Corporation, American Fork, UT, United States |
| Recall initiated | 2019-09-10 |
| Classified | 2020-09-11 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CO, DO, GB, ID, JO, MX, PE |
| Quantity | 197 units |
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 for recall
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.
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-2956-2020. 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.