Accuray Incorporated

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 housi…

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 housi…

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.

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.

The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.

"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

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.

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

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.

Uncontrolled couch Z-axis movement (descent)

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® Robot…

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.

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.

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.

Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.

A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.

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 small…