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