Reported Oct 12, 2016 · Terminated
TriFoillmaging Triumph/Triumph II Research CT scanners.
Northridge Tri-Modality Imaging,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Northridge Tri-Modality Imaging, · 9457 de Soto Ave · Chatsworth, CA · 91311-4920
Is this the product you have?
- TriFoillmaging Triumph/Triumph II Research CT scanners.
- Lot codes and dates
- n/a
- Amount recalled
- 3
Why it was 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)
This product could cause temporary or reversible health problems — stop using it.
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