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Recall Observatory FDA recall evidence

Device product

TriFoillmaging Triumph/Triumph II Research CT scanners.

Z-2833-2016

May 24, 2016

Class II

Product summary

Firm
Northridge Tri-Modality Imaging,
Event
Event 74838
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-2833-2016

Official wording

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)

Code information: n/a

Distribution pattern: USA Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)