FDA Device recall Z-2833-2016
TriFoillmaging Triumph/Triumph II Research CT scanners
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of TriFoillmaging Triumph/Triumph II Research CT scanners by Northridge Tri Modality Imaging, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2833-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-24 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Northridge Tri Modality Imaging |
| Distribution | n/a |
Product
TriFoillmaging Triumph/Triumph II Research CT scanners.
Reason
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)
Identifiers
| code_info | n/a |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2833-2016%22
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