Accuray Inc Recalls
Showing 1-12 of 12 recalls
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned.
Accuray sent an "URGENT DEVICE CORRECTION" letter dated July 6, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to assure the LINAC cover is secure following reattachment and adhere to and follow the instructions included in the letter. Note: A new design is being developed, and will be distributed to user base once available. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non-USA) or customersupport@accuray.com.
CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.
Accuray Inc., sent an "URGENT DEVICE CORRECTION" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA), +1-408-716-4700 (non-USA) or email: customersupport@accuray.com.
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.
The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated December 29, 2009, to all customers. The letter described the product, problem, and action to be taken by the customers. The customers were instructed to verify correctness of the CT number to relative electron density and Mass Density Calibration curves. Note: A patch is being developed to address this issue. Accuray Customer Support will contact the customers regarding further resolution. If you have any questions or concerns regarding this issue, please contact Accuray Customer Support at +1-877-668-8667 (USA) or +1-408-716-4700 (non USA) or by email: customersupport@accuray.com.
Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available.
The firm, Accuray, sent an "URGENT DEVICE CORRECTION" letter dated January 18, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to load the plan and recalculate the dose to reflect the current state of beam, compare the reloaded plan and the recalculated plan to verify maximum dose and prescription values, and re-prescribe and save to overwrite to existing plan if necessary. The firm is developing a patch/software update to address the issue and a Accuray Customer Support person will contact the customer regarding further resolutions. If you have any questions or concerns regarding this issue, contact Accuray Customer Support at +1-877-668-8667(USA) or +1-408-716-4700 (non USA) or email: customersupport@accuray.com.
CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.
The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly.
Accuracy Inc., sent an URGENT ADVISORY NOTIFICATION letter, dated March 16, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their system to see if it was affected. Customers were instructed to contact Accuracy Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 or e-mail customersupport@accuracy.com to schedule service.
RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA. 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.
Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
Consignees were notified verbally about the issue when an inspection was scheduled.
CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment for planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area.
Accuray, Inc. issued an "Urgent Device Correction" notice dated June 22, 2009. The consignees were informed of the defect including methods for detecting the error. The firm is in the process of developing a software patch to address the issue. For further information, contact Accuray, Inc. Customer Support at +1-877-668-8667 (US) or +1-408-716-4700 (outside US) or customersupport@accuray.com.
Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
An Urgent Advisory Notification letter dated November 14, 2008 was issued to all sites via Fed Ex. The letter identifies the issue and required actions. The user was instructed not to modify current extrapolation depth settings and to contact Accuray Incorporated Customer Support prior to making any changes. Please direct any questions or concerns regarding this issue to Accuray Incorporated Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com.
Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com for additional information.
CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher.
Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users.
On April 16, 2008, the firm issued notifications via fedex to affected sites. In addition, installation and upgrade procedures will be updated to incorporate a step which decommissions sample beam data. If you have questions, contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or send and email to customersupport@accuray.com.
RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and r
Product may not be tensioned properly, potentially causing unexpected rotation or descent.
All affected sites were notified of the potential problem via Customer Advisory Notice dated 30 October 2008. The letter states required actions that the customer should follow at the beginning of each treatment day. The tension of the belt drive and the support bolts in question will be inspected by Accuray Field Service personnel at the affected facilities. In addition, the preventive maintenance procedure will be updated to include regular inspection and replacement of the belt-drive. Any questions or concerns regarding this issue should be directed to Accuray Customer Support at 1-877-668-8667 or 1-408-716-4700 or customersupport@accuray.com.
Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.
Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.
The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com.