TriFoillmaging CT Scanners Recalled for X-Ray Compliance Issues
Northridge Tri-Modality Imaging is recalling three TriFoillmaging Triumph/Triumph II Research CT scanners because they may not meet federal X-ray safety standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving regulatory non-compliance without reported harm.
Plain-English summary
Northridge Tri-Modality Imaging, Inc. dba TriFoillmaging is recalling three TriFoillmaging Triumph/Triumph II Research CT scanners. The firm determined that these scanners, which were produced by Northridge Trimodality Imaging 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).
The recall covers units distributed in the USA. The source text does not specify the number of affected patients or report any specific injuries or illnesses associated with the non-compliance.
Consumers and facilities using these specific research CT scanners should contact the recalling firm for further instructions regarding the compliance issue.
The recalled product
- Product
- TriFoillmaging Triumph/Triumph II Research CT scanners.
- Manufacturer
- Northridge Tri-Modality Imaging,
- Category
- Medical Device — CT Scanner
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- n/a
Distribution
Distribution scope not specified by the agency.
Related recalls
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- HighPhilips Brilliance iCT Computed Tomography X-ray System Recall for Torque Wrench Malfunction
FDA (Devices) · 2015-06-10
- LowPhilips CT Scanner Recall for Incorrect Product Label Rating
FDA (Devices) · 2016-11-23
- LowPhilips CT System Recalled for Incorrect Label Rating
FDA (Devices) · 2016-11-23
- HighPhilips CT Systems Recalled for Improper Vertical Motor Assembly
FDA (Devices) · 2015-01-21
- LowPhilips Brilliance iCT Computed Tomography System Recalled for Labeling Error
FDA (Devices) · 2016-11-23
- HighPhilips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality
FDA (Devices) · 2013-07-10