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Northridge Tri-Modality Imaging, recalls TriFoillmaging Triumph/Triumph II Research CT scanners.
Recalled October 12, 2016 · FDA recall Z-2833-2016 · Northridge Tri-Modality Imaging
Hazard
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 Class II
Units
3
Sold at
USA Distribution
Description
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)
Product
TriFoillmaging Triumph/Triumph II Research CT scanners.
Manufacturer(s)
Northridge Tri-Modality Imaging,
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →