Recall Z-2833-2016— Northridge Tri-Modality Imaging,
Class II · Terminated
Class II FDA medical device recall by Northridge Tri-Modality Imaging,, initiated 2016-05-24, terminated 2016-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: TriFoillmaging Triumph/Triumph II Research CT scanners.. 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).
- Recalling firm
- Northridge Tri-Modality Imaging,
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-24
- Terminated
- 2016-10-06
- Firm location
- Chatsworth, CA, United States
Product description
TriFoillmaging Triumph/Triumph II Research CT scanners.
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)
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