Drug recall
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves…
FDA recall event 85347 · Class II · Novarad Corporation
Key facts
| Event ID | 85347 |
|---|---|
| Recall numbers | Z-2956-2020 |
| Recalling firm | Novarad Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 10, 2019 |
| Report date | Sep 23, 2020 |
| Termination date | Jun 30, 2021 |
| City | American Fork |
| State | UT |
| Country | United States |
| FEI number | 1000117423 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: