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Terminated

TriFoillmaging Triumph/Triumph II Research CT scanners.

FDA Recall Z-2833-2016 · Posted None

Recalling FirmNorthridge Tri-Modality Imaging,
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-05-24
Date Terminated2016-10-06
Product Quantity3

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)

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

USA Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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