Recall Z-1613-2016— Novarad Corporation

Name: FDA recall Z-1613-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-16

Class II · Terminated

Class II FDA medical device recall by Novarad Corporation, initiated 2015-11-16, terminated 2016-08-17. It names one FDA 510(k) clearance: K132853. Product: NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation. Reason: The SUV values that are being calculated in the PET/CT fusion tool are incorrect..

Recalling firm: Novarad Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-16
Terminated: 2016-08-17
Firm location: American Fork, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K132853 — NOVAPACSNovarad Corp.·cleared 2014-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.