FDA Medical Device Recalls (openFDA)
Northridge Tri-Modality Imaging,: TriFoillmaging Triumph/Triumph II Research CT scanners.
- Recall number
- Z-2833-2016
- Recalling firm
- Northridge Tri-Modality Imaging,
- Product
- TriFoillmaging Triumph/Triumph II Research CT scanners.
- Status
- Terminated
- Initiated
- 2016-05-24
- Posted
- not on file
- Terminated
- 2016-10-06
- 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)
- 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
- 3
- Distribution
- USA Distribution
- Lot, serial or model codes
- n/a
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3010878127
- Firm city
- Chatsworth
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28