Company: Novarad Corporation
Date of Enforcement Report: 9/23/2020
Class II

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.

Recall Number: Z-2956-2020

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.

RECALLING FIRM/MANUFACTURER

Novarad Corporation on 9/10/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

197 units

DISTRIBUTION

U.S. Nationwide and International