Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2833-2016 — TriFoillmaging Triumph/Triumph II Research CT scanners.

U.S. FDA — Device Enforcement · United States · 2016-05-24 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2833-2016
Date of alert
2016-05-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Northridge Tri-Modality Imaging,
Product category
device
Product type
Devices
Reported risk: 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)
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.