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.

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.

The firm issued their Urgent Medical Device Correction Notice on 09/24/2019 and letters were sent via certified mail. The issue affected versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8. Customers were instructed to view in the NovaPACS Study Browser's menu what version they are running by selecting "Help" and then selecting "About". The firm informs that the issue has been fixed in versions 8.6.14.62 and 8.7.8.12 and will be in all future releases of the software. It is further explained that you can eliminate the possibility of the malfunction occurring by contacting Technical Support to arrange for an upgrade to a corrected version of the software. This correction is available to all affected customers at no cost and will be included in all future upgrades. Customers will need to FAX, mail, or email the Acknowledgement and Receipt Form back to the firm. For questions or concerns regarding the notification or would like to request an upgrade, you can contact Technical Support at (801) 221-5895.