Z-2640-2026Class II

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

Name: Z-2640-2026 Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Creator: Accuray Incorporated
Published: 2026-06-16
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2026-06-16 / Open, Classified / root cause: software

FDA source

Accuray Incorporated began a recall of Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator on 2026-06-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2640-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-16
Posted: 2026-07-01
Recalling firm: Accuray Incorporated
Product: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: Accuray issued am Urgent Field Safety Notice to it consignees via hand delivered letter on 6/16/2026. The notice explained the issue, potential 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 instruments. For questions, please contact Accuray Customer Support by phone or email, using the Service Request form available at http://www.accuray.com/service-requests.
Quantity in commerce: 48 units
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.
Product codes and lots: All systems prior with software version 11X that utilize the Exchange Table

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2640-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2640-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code IYE

K170788Class IICyberKnife Treatment Delivery SystemAccuray Incorportaed / cleared 2017-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)