The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2640-2026·Announced 2026-07-08

Cyberknife Treatment Delivery System Collimator Docking Failure Risk

Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves a risk of a heavy device component falling on a patient or operator, which represents a significant injury risk. Although no specific illnesses or injuries are reported in the source text, the structural failure and injury mechanism meets the threshold for Severe classification under the Class II criterion with documented risk-of-harm potential.

Plain-English summary

Accuray Incorporated is recalling certain Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer and Linear Accelerator devices. The recall affects 48 units distributed worldwide, including throughout the United States and in China, Colombia, Czech Republic, France, Hong Kong, Japan, Republic of Korea, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, and Ukraine.

In certain cases, the collimator may not fully dock into the system, triggering a system interlock that 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, posing a risk of injury.

The recall applies to all systems with software version 11X that utilize the Xchange Table. Healthcare facilities and users of affected systems should contact Accuray Incorporated for information about service or replacement options.

The recalled product

Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Manufacturer
Accuray Incorporated
Category
Medical Device — Radiation Therapy / Linear Accelerator
Hazard
Affected units
48

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All systems prior with software version 11X that utilize the Exchange Table

Distribution

Distributed nationwide across the United States.

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