Home / Recalls / Accuray Incorporated / Z-2644-2026

Z-2644-2026 Class II Ongoing

Recalled by Accuray Incorporated — Madison, WI

FDA device recall Z-2644-2026 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: 292 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
292 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 - US Nationwide and and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kenya, Korea, Republic of, Liechtenstein, Lithuania, Luxembourg, Macao, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Code Information

ALL Cyberknife systems running software version 11.X and higher that utilize the Exchange Table.

Other recalls by Accuray Incorporated

  • Z-2640-2026 Class II — Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator (June 16, 2026)
  • Z-1023-2025 Class II — CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may b (December 23, 2024)
  • Z-2489-2023 Class II — Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the (August 3, 2023)
  • Z-1272-2021 Class II — CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided (February 26, 2021)
  • Z-0784-2021 Class II — TomoTherapy Treatment System - Product Usage: used as an integrated system for t (December 10, 2020)
  • Z-0785-2021 Class II — TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an inte (December 10, 2020)
  • Z-0408-2019 Class II — CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicate (September 26, 2018)
  • Z-3211-2018 Class II — Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is use (August 31, 2018)
  • Z-1696-2019 Class II — CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System (April 10, 2018)
  • Z-1697-2019 Class II — CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radi (April 10, 2018)

FDA data resources