Reported Sep 23, 2020 · Terminated
NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves,…
Novarad Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novarad Corporation · 752 E 1180 S Ste 200 · American Fork, UT · 84003-3561
Is this the product you have?
- 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.
- Lot codes and dates
NovaPACS versions 8.6.88.6.98.6.118.6.128.6.148.7.48.7.6and 8.7.8
- Amount recalled
- 197 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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