fda
18 records
FDA Device Recall: CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may b
2025-02-05
Class II — 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 remov...
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FDA Recall: Accuray Incorporated — Class II
20210324
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. | Product: CyberKnife Treatment Delivery System - Product Usage:...
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FDA Device Recall: CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided
2021-03-24
Class II — The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
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FDA Device Recall: TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an inte
2021-01-13
Class II — "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
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FDA Device Recall: CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System
2019-06-12
Class II — 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 inter...
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FDA Device Recall: CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicate
2018-11-14
Class II — 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 ...
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FDA Device Recall: Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is use
2018-09-26
Class II — 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
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FDA Device Recall: TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treat
2018-01-03
Class II — Uncontrolled couch Z-axis movement (descent)
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FDA Device Recall: TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatme
2018-01-03
Class II — Uncontrolled couch Z-axis movement (descent)
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FDA Device Recall: TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatm
2018-01-03
Class II — Uncontrolled couch Z-axis movement (descent)
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FDA Recall: Accuray Incorporated — Class II
20161228
Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV P | Product: CyberKnife Robotic Radiosurgery System...
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FDA Device Recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The
2016-12-28
Class II — 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 modulato...
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FDA Device Recall: CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package
2016-02-17
Class II — 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 cont...
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FDA Device Recall: CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable A
2014-11-26
Class II — 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 Co...
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FDA Device Recall: Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale,
2014-02-05
Class II — Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
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FDA Recall: Accuray Incorporated — Class II
20130501
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. | Product: RoboCouch Patient Positioning System ...
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FDA Device Recall: RoboCouch Patient Positioning System Product Usage: is intended for use in
2013-05-01
Class II — A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
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FDA Device Recall: Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medica
2013-04-24
Class II — 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 radiat...
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lobbying
1 records
Lobbying Firm: ACCURAY INCORPORATED
Registered lobbying firm — Sunnyvale, CA — Manufacturer of the CyberKnife Radiosurgery System
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ny_corps
1 records
NY Corp: ACCURAY INCORPORATED
2016-07-15
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Delaware
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SEC EDGAR
1 records
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