Northridge Tri-Modality Imaging, recalls TriFoillmaging Triumph/Triumph II Research CT scanners.
- Recall date
- May 24, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2833-2016
- FDA classification
- Class II
- Brand / firm
- Northridge Tri-Modality Imaging,
- Sold / distributed
- USA Distribution
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)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TriFoillmaging Triumph/Triumph II Research CT scanners.
Get recall alerts
Free email alert whenever Northridge Tri-Modality Imaging, has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Northridge Tri-Modality Imaging,