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

Recall Z-0218-2015 — CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treat

U.S. FDA — Device Enforcement · United States · 2014-10-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0218-2015
Date of alert: 2014-10-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Accuray Incorporated
Product category: device
Product type: Devices

Reported risk: Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.

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.

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