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

Recall Z-0439-2014 — C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision

U.S. FDA — Device Enforcement · United States · 2013-10-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0439-2014
Date of alert: 2013-10-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Varian Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.

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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