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U.S. Department of Health and Human Services

Class 2 Device Recall Triumph CT and Triumph II CT scanners

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  Class 2 Device Recall Triumph CT and Triumph II CT scanners see related information
Date Initiated by Firm May 24, 2016
Create Date September 30, 2016
Recall Status1 Terminated 3 on October 06, 2016
Recall Number Z-2833-2016
Recall Event ID 74838
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product TriFoillmaging Triumph/Triumph II Research CT scanners.

Code Information n/a
Recalling Firm/
Northridge Tri-Modality Imaging,
9457 de Soto Ave
Chatsworth CA 91311-4920
For Additional Information Contact
Manufacturer 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 Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.