The Recall Desk

Manufacturer

Accuray Incorporated

22 recalls in our database name Accuray Incorporated as the manufacturing or recalling firm.

What the numbers show

Total
22
Critical
0
Severe
7
Most recent
2026-07-08

Of the 22 recalls from Accuray Incorporated we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (32%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

  • SevereFDA (Devices)·Z-2644-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2640-2026·2026-07-08

    Cyberknife Treatment Delivery System Collimator Docking Failure Risk

    Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.

    Product
    Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2025·2025-02-05

    CyberKnife Treatment System: Internal Snap Ring Detachment Risk

    Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.

    Product
    CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2023·2023-09-06

    Upper roller bracket for Radixact gantry enclosure may lack adequate service clearance

    Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.

    Product
    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2021·2021-03-24

    Accuray CyberKnife Treatment Delivery System Recalled for Loose Set Screws

    Accuray is recalling 243 CyberKnife Treatment Delivery Systems because set screws can loosen, allowing the treatment couch to roll unexpectedly.

    Product
    CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0785-2021·2021-01-13

    Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error

    Accuray is recalling eight TomoTherapy Treatment Delivery Systems because an MLC tickle error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2021·2021-01-13

    Accuray TomoTherapy System Recalled for MLC Tickling Error

    Accuray is recalling seven TomoTherapy Treatment Systems because an MLC tickling error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2019·2019-06-12

    Accuray Recalls CyberKnife M6 Systems Due to Collimator Housing Drop Risk

    Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: Cyb
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1697-2019·2019-06-12

    Accuray CyberKnife VSI Robotic Radiosurgery Systems Recalled for Collimator Housing Drop

    Accuray is recalling 43 CyberKnife VSI systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.

    Product
    CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0408-2019·2018-11-14

    Accuray Recalls CyberKnife M6 Systems Due to Wrist Component Failure Risk

    Accuray is recalling 93 CyberKnife M6 systems worldwide due to manufacturing variations in the robot wrist that may cause premature component failure.

    Product
    CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3211-2018·2018-09-26

    Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy

    Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.

    Product
    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0289-2018·2018-01-03

    Accuray TomoHDA System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.

    Product
    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targe
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0286-2018·2018-01-03

    Accuray Hi-Art System Recalled for Uncontrolled Couch Movement

    Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.

    Product
    Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other tar
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0288-2018·2018-01-03

    Accuray TomoH System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.

    Product
    TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targete
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0287-2018·2018-01-03

    Accuray TomoHD System Recalled for Uncontrolled Couch Movement

    Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.

    Product
    TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other target
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0865-2017·2016-12-28

    Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Electric Shock Risk

    Accuray is recalling 115 CyberKnife Robotic Radiosurgery Systems (models G3, G4, VSI) due to a potential electric shock hazard during maintenance.

    Product
    CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0734-2017·2016-12-21

    Accuray Recalls CyberKnife Systems Due to Unexpected Robot Motion

    Accuray is recalling 40 CyberKnife Robotic Radiosurgery Systems with software version 10.6 due to a potential safety issue involving unexpected treatment robot motion when removing an accessory.

    Product
    CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy fo
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0771-2016·2016-02-17

    Accuray CyberKnife Robotic Recall for Potential Gun Box Mounting Bracket Failure

    Accuray is recalling CyberKnife Robotic systems because the gun box mounting bracket may fail, allowing the gun box to fall and contact a patient.

    Product
    CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and condi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2015·2014-11-26

    Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Software Upgrade Issue

    Accuray is recalling 84 CyberKnife Robotic Radiosurgery Systems to correct a potential safety issue related to upgrading the Treatment Delivery Software for the first generation IRIS Variable Aperture Collimator.

    Product
    CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0828-2014·2014-02-05

    Accuray CyberKnife Robotic Radiosurgery System Recall for Mounting Assembly Issue

    Accuray is recalling 302 CyberKnife systems worldwide due to a potential safety issue where the Synchrony Boom Arm Mounting Assembly may detach.

    Product
    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2013·2013-05-01

    Accuray RoboCouch Patient Positioning System Recalled for Defective Gearboxes

    Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.

    Product
    RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2013·2013-04-24

    Accuray CyberKnife Iris Variable Aperture Collimator Recall for Beam Axis Shift

    Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.

    Product
    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide