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Accuray Incorporated Recalls
22 recalls on record · April 24, 2013 to July 8, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026Medical DevicesFDA
Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Hazard: 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.
July 8, 2026Medical DevicesFDA
Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Hazard: 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.
February 5, 2025Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R
Hazard: 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.
September 6, 2023Medical DevicesFDA
Accuray Incorporated recalls Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Hazard: 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 possible injury to the service personnel.
March 24, 2021Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision
Hazard: The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
January 13, 2021Medical DevicesFDA
Accuray Incorporated recalls TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and preci
Hazard: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
January 13, 2021Medical DevicesFDA
Accuray Incorporated recalls TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radi
Hazard: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
June 12, 2019Medical DevicesFDA
Accuray Incorporated recalls CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010
Hazard: 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 collimator housing to partially attach.
June 12, 2019Medical DevicesFDA
Accuray Incorporated recalls CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatme
Hazard: 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 collimator housing to partially attach.
November 14, 2018Medical DevicesFDA
Accuray Incorporated recalls CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guide
Hazard: 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.
September 26, 2018Medical DevicesFDA
Accuray Incorporated recalls Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Hazard: 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
January 3, 2018Medical DevicesFDA
Accuray Incorporated recalls TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an
Hazard: Uncontrolled couch Z-axis movement (descent)
January 3, 2018Medical DevicesFDA
Accuray Incorporated recalls TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an i
Hazard: Uncontrolled couch Z-axis movement (descent)
January 3, 2018Medical DevicesFDA
Accuray Incorporated recalls TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an
Hazard: Uncontrolled couch Z-axis movement (descent)
January 3, 2018Medical DevicesFDA
Accuray Incorporated recalls Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as
Hazard: Uncontrolled couch Z-axis movement (descent)
December 28, 2016Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System i
Hazard: 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 limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
December 21, 2016Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Ra
Hazard: 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.
February 17, 2016Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robo
Hazard: 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.
November 26, 2014Medical DevicesFDA
Accuray Incorporated recalls CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is
Hazard: 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.
February 5, 2014Medical DevicesFDA
Accuray Incorporated recalls Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning
Hazard: Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
May 1, 2013Medical DevicesFDA
Accuray Incorporated recalls RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patien
Hazard: A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
April 24, 2013Medical DevicesFDA
Accuray Incorporated recalls Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy sys
Hazard: 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 significant clinical impact to plans created using the smallest collimators.