FDAClass IIOctober 12, 2016

TriFoillmaging Triumph/Triumph II Research CT scanners recall

TriFoillmaging Triumph/Triumph II Research CT scanners.

Why was TriFoillmaging Triumph/Triumph II Research CT scanners recalled?

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)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

n/a

Product
TriFoillmaging Triumph/Triumph II Research CT scanners.
Recalling firm
Northridge Tri-Modality Imaging,
Quantity
3
Distribution
USA Distribution
Recall date
October 12, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls