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

FDA device recall Z-2644-2026 · posted 2026-07-01 · Open, Classified

Recall details

Recalling firm

Accuray Incorporated

Reason for recall

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.

Action taken

Accuray issued an Urgent Field Safety Notice to its consignees via hand delivered letter on 6/16/2026. The notice explained the issue, risk to health, and provided the following safety instructions: "This condition may occur during collimator housing drop off or pick up while the collimator housing is positioned over the Xchange table. The system will interlock, stop motion, and display a message at the operator console to contact service. If an interlock occurs: (1) remove the patient from the treatment room before troubleshooting, (2) do not initiate treatment robot motion from the in-room control pendant, and (3) contact Accuray Service to safely release the collimator housing." Accuray is correcting the units. For questions, please contact Accuray Customer Support by phone or email, using the Service Request form available at http://www.accuray.com/service-requests.

Root cause

Software design

Status

Open, Classified

Product code

IYE

Quantity affected

292 units

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

Date initiated

2026-06-16

Date posted

2026-07-01

Location

Madison, WI

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