Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Summary
The FDA issued a Class II for Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator by 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 .
Details
Source
Device Recall
External ID
Z-2640-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Lot/Code Info: All systems prior with software version 11X that utilize the Exchange Table
Quantity Affected: 48 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-16
Company
Madison, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Accuray Incorporated has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accuray Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accuray Incorporated have FDA actions?
Accuray Incorporated has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2640-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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