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

Recall Z-1402-2013 — Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

U.S. FDA — Device Enforcement · United States · 2013-04-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1402-2013
Date of alert: 2013-04-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Elekta, Inc.
Product category: device
Product type: Devices

Reported risk: Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

Recall Z-1402-2013 — Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

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