Recall Z-2956-2020— Novarad Corporation
Class II · Terminated
Class II FDA medical device recall by Novarad Corporation, initiated 2019-09-10, terminated 2021-06-30. It names one FDA 510(k) clearance: K171754. 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: 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
- Novarad Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-10
- Terminated
- 2021-06-30
- Firm location
- American Fork, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.