FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Medical device · Recalled July 8, 2026

Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer recall — Accuray Incorporated

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2640-2026
Brand
Accuray Incorporated
Classification
Class II
Units affected
48 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Madison, WI, United States
Firm address
1240 Deming Way, N/A, 53717-1954

Identifying details (verbatim from the notice)

Product codes / lots
All systems prior with software version 11X that utilize the Exchange Table
Distribution
Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.
Firm notified the public via
Letter
FDA event ID
99075
Recall initiated
June 16, 2026
FDA classified
July 1, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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