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 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. |
| 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. |
| Quantity | 197 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Colombia, Dominican Republic, Indonesia, Jordan, Mexico, Peru, Phillipines, and United Kingdom. |
| Initiated | 2019-09-10 |
| Classified | 2020-09-11 |
| Terminated | 2021-06-30 |
| Recall number | Z-2956-2020 |
| 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-2956-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85347/
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