Accuray Incorporated: Cyberknife Treatment Deliver System Equipped With The Xchange Robotic Collimator Changer; Linear Accelerator

Recall Summary Accuray's Cyberknife Treatment Delivery System with Xchange Robotic Collimator Changer is being recalled because a collimator (a radiation-shaping device) may not fully dock properly, and if room personnel then activate motion using a control pendant in the treatment room, the collimator could release and fall from the machine. The recall affects systems distributed worldwide, including throughout the United States and multiple other countries.

Recalling firm

Accuray Incorporated

Product

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

Reason

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.

Classification

Class II

Category

medical device recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-16

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Worldwide - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico,...

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/b92743cb-e49e-43e3-aa26-f759157b1784