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Terminated

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

FDA Recall Z-1613-2016 · Posted 2016-05-06

Recalling FirmNovarad Corporation
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-11-16
Date Terminated2016-08-17
Product Quantity2,386

Reason for Recall

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

Firm Action

Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.

Root Cause

Software design

Distribution Pattern

Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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