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 8.6.8
    • 8.6.9
    • 8.6.11
    • 8.6.12
    • 8.6.14
    • 8.7.4
    • 8.7.6
    • and 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Novarad Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 30, 2021 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.