Z-2640-2026 Class II Ongoing
FDA device recall Z-2640-2026 was initiated by Accuray Incorporated on June 16, 2026 and is designated Class II. 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 recall status is ongoing. Affected quantity: 48 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- June 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 units
Product Description
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
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 Pattern
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.
Code Information
All systems prior with software version 11X that utilize the Exchange Table