# FDA recall Z-2956-2020

> **Novarad Corporation** · Class II · device recall initiated 2019-09-10.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2956-2020
- **Recalling firm:** Novarad Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-10
- **Report date:** 2020-09-23
- **Termination date:** 2021-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** American Fork, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2956-2020

## Citation

> AI Analytics. FDA recall Z-2956-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2956-2020. Source: US FDA. Licensed CC0.

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