Recall Z-2833-2016 ยท JAK System, X-Ray, Tomography, Computed
Northridge Tri-Modality Imaging,
TriFoillmaging Triumph/Triumph II Research CT scanners.
| Date | May 24, 2016 |
| Status | Terminated |
| 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 Imagi |
| Quantity | 3 |
| Distribution | USA Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.