Accuray recalls

Accuray appears in 22 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
  FDA Device · Class II · 2026-07-08 · Accuray
  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 enter the treatment room and initiate motion using the in-room contro…
• Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
  FDA Device · Class II · 2026-07-08 · Accuray
  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 enter the treatment room and initiate motion using the in-room contro…
• CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System
  FDA Device · Class II · 2025-02-05 · Accuray
  Reason: Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
• Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
  FDA Device · Class II · 2023-09-06 · Accuray
  Reason: It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in po…
• CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l…
  FDA Device · Class II · 2021-03-24 · Accuray
  Reason: The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
• TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radi…
  FDA Device · Class II · 2021-01-13 · Accuray
  Reason: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
• TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, ster…
  FDA Device · Class II · 2021-01-13 · Accuray
  Reason: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
• CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c)…
  FDA Device · Class II · 2019-06-12 · Accuray
  Reason: There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the…
• CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robot…
  FDA Device · Class II · 2019-06-12 · Accuray
  Reason: There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the…
• CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosur…
  FDA Device · Class II · 2018-11-14 · Accuray
  Reason: A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
• Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
  FDA Device · Class II · 2018-09-26 · Accuray
  Reason: the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System
• Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system fo…
  FDA Device · Class II · 2018-01-03 · Accuray
  Reason: Uncontrolled couch Z-axis movement (descent)
• TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t…
  FDA Device · Class II · 2018-01-03 · Accuray
  Reason: Uncontrolled couch Z-axis movement (descent)
• TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for…
  FDA Device · Class II · 2018-01-03 · Accuray
  Reason: Uncontrolled couch Z-axis movement (descent)
• TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t…
  FDA Device · Class II · 2018-01-03 · Accuray
  Reason: Uncontrolled couch Z-axis movement (descent)
• CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatm…
  FDA Device · Class II · 2016-12-28 · Accuray
  Reason: Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limite…
• CyberKnife Robotic Radiosurgery System using software version 10.6
  FDA Device · Class II · 2016-12-21 · Accuray
  Reason: Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife¿ Systems with software version 1 0.6.
• CyberKnife Robotic
  FDA Device · Class II · 2016-02-17 · Accuray
  Reason: The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
• CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator
  FDA Device · Class II · 2014-11-26 · Accuray
  Reason: Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
• Accuray CyberKnife Robotic Radiosurgery System
  FDA Device · Class II · 2014-02-05 · Accuray
  Reason: Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
• RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and…
  FDA Device · Class II · 2013-05-01 · Accuray
  Reason: A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
• Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Va…
  FDA Device · Class II · 2013-04-24 · Accuray
  Reason: A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose…