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

Recall Z-0865-2017 — CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation tre

U.S. FDA — Device Enforcement · United States · 2016-12-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0865-2017
Date of alert
2016-12-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Accuray Incorporated
Product category
device
Product type
Devices
Reported risk: Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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