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Class IIOngoing

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

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Accuray Incorporated
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99075…

Products

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

    Codes/lots: All systems prior with software version 11X that utilize the Exchange TableQuantity: 48 unitsRecall no. Z-2640-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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