Recall – PACS viewer reference line inaccurately placed

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


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


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.


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


197 units


U.S. Nationwide and International

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