Reported May 18, 2016 · Terminated

NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

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 versions 8.3.7
    • 8.4.2
    • 8.4.3
    • and 8.4.4. Novarad Corporation
Lot codes and dates
    • Versions 8.3.7
    • 8.4.2
    • 8.4.3
    • and 8.4.4
Amount recalled
2,386

Where it was sold

  • Nationwide
  • VA

Why it was recalled

The SUV values that are being calculated in the PET/CT fusion tool are incorrect.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 17, 2016 · Data as of Sep 19, 6:02 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.