FDA-Device2016-10-12Class II
TriFoillmaging Triumph/Triumph II Research CT scanners.
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)
Sold states
USA Distribution
Affected count
3
Manufactured in
9457 de Soto Ave, N/A, Chatsworth, CA, United States
Products
TriFoillmaging Triumph/Triumph II Research CT scanners.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2833-2016Don't want to check this manually?
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