Z-2833-2016 Class II Terminated
FDA device recall Z-2833-2016 was initiated by Northridge Tri-Modality Imaging, on May 24, 2016 and is designated Class II. 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… The recall status is terminated (terminated October 6, 2016). Affected quantity: 3.
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