Z-2833-2016Class II

TriFoillmaging Triumph/Triumph II Research CT scanners

Name: Z-2833-2016 TriFoillmaging Triumph/Triumph II Research CT scanners
Creator: Northridge Tri-Modality Imaging,
Published: 2016-05-24
License: https://open.fda.gov/license/

Northridge Tri-Modality Imaging / initiated 2016-05-24 / Terminated

FDA source

Northridge Tri-Modality Imaging, began a recall of TriFoillmaging Triumph/Triumph II Research CT scanners on 2016-05-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2833-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-24
Posted: 2016-09-30
Terminated: 2016-10-06
Recalling firm: Northridge Tri-Modality Imaging
Product: TriFoillmaging Triumph/Triumph II Research CT scanners.
Product code: JAK System, X-Ray, Tomography, Computed
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)
FDA root cause: Radiation Control for Health and Safety Act
Action: TriFoil lmaging planned action to bring defect into Compliance: 1. All repairs were performed at customer facilities. Customers were contacted by phone to arrange a convenient repair time. 2. TriFoil service engineers installed a collimator on each of the affected cabinet x-ray systems to bring their emission rates into compliance with the emission limit in the performance standard. 3. Full radiation surveys were performed, at maximum exposure settings, to verify each repair was effective. 4. All costs associated with the repair and follow-up testing were paid directly by TriFoil Imaging. CDRH approves the CAP and understands that the CAP was completed on August 29, 2016. For further questions please call (818) 709-2468.
Quantity in commerce: 3
Distribution: USA Distribution
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2833-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2833-2016	Class II	Terminated	FDA Mandated	2016-10-12	2016-09-30

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)