Home / Recalls / Northridge Tri-Modality Imaging, / Z-2833-2016

Z-2833-2016 Class II Terminated

Recalled by Northridge Tri-Modality Imaging, — Chatsworth, CA

Recall Details

Product Type: Devices
Report Date: October 12, 2016
Initiation Date: May 24, 2016
Termination Date: October 6, 2016
Voluntary/Mandated: FDA Mandated
Product Quantity: 3

Product Description

TriFoillmaging Triumph/Triumph II Research CT scanners.

Reason for Recall

The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma Medica-Ideas, Inc and field upgraded with a replacement x-ray tube) may be out of compliance with 21 CFR 1020.40 (Cabinet X-ray standards)

Distribution Pattern

USA Distribution

Code Information

n/a