Cyberknife Treatment Deliver System equipped with the… recallZ-2640-2026 · Accuray Incorporated · initiated Jun 16, 2026
Class II Open, Classified All recalls posted in July 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Accuray Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2640-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 16, 2026
- Posted by the FDA
- Jul 1, 2026
- Recalling firm
- Accuray Incorporated
- Quantity
- 48 units
- Product code
- IYE
- FDA submissions
- K170788
- 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 description
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Code information (models, lots, serial numbers)
All systems prior with software version 11X that utilize the Exchange Table
Other devices under the same FDA submission
1 device cleared under K170788 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CyberKnife® Treatment Delivery System 0660000Accuray Incorporated · Accelerator, Linear, Medical9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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