Monday, October 26, 2026 · Daily editionET --:--:--

Recall

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

Accuray Incorporated · 16 June 2026

Status
Recall open, classified
Why, in the FDA's words
“In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.”
Recall began
16 June 2026
Company
Accuray Incorporated
Device type
Product code (IYE)
Concerns
K170788

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