Novarad Corporation: Medical Device Recall in 2016 - (Recall #: Z-1613-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 16, 2015

Date Posted: May 18, 2016

Recall Number: Z-1613-2016

Event ID: 73977

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,386

Code Information:

Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated