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Home › FDA recalls › Cyberknife Treatment Deliver System equipped with the Xchang
CLASS II · ModerateFDA

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

📅 Jun 16, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Jun 16, 2026
Reported
Jul 8, 2026
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.
Status
Ongoing
Quantity
48 units
Lot / codes
All systems prior with software version 11X that utilize the Exchange Table
Company location
Madison, WI
Recall type
Voluntary: Firm initiated
Recall number
Z-2640-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2640-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.