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

Recall Z-2567-2014 — C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intende

U.S. FDA — Device Enforcement · United States · 2014-06-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2567-2014
Date of alert: 2014-06-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Varian Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.

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.

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.

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