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Recall

CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System

Accuray Incorporated · 10 April 2018

Status
Recall terminated
Why, in the FDA's words
“There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.”
Recall began
10 April 2018
Company
Accuray Incorporated
Device type
Product code (IYE)

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database