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

CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: 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 th — recall Z-0771-2016

U.S. FDA — Device Enforcement · United States · 2016-01-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0771-2016
Date of alert: 2016-01-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Accuray Incorporated
Product category: device
Product type: Devices

Reported risk: The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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