Home / Recalls / Novarad Corporation / Z-1613-2016

Z-1613-2016 Class II Terminated

Recalled by Novarad Corporation — American Fork, UT

FDA device recall Z-1613-2016 was initiated by Novarad Corporation on November 16, 2015 and is designated Class II. Reason for recall: The SUV values that are being calculated in the PET/CT fusion tool are incorrect. The recall status is terminated (terminated August 17, 2016). Affected quantity: 2,386.

Recall Details

Product Type
Devices
Report Date
May 18, 2016
Initiation Date
November 16, 2015
Termination Date
August 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,386

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4

Other recalls by Novarad Corporation

  • Z-2956-2020 Class II — NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication sy (September 10, 2019)
  • Z-2659-2016 Class II — NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. P (August 12, 2016)
  • Z-2151-2016 Class II — NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by No (May 9, 2013)

FDA data resources