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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Robotic Radiosurgery System Device

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 Class 2 Recall
CyberKnife Robotic Radiosurgery System Device
see related information
Date Posted February 02, 2011
Recall Status1 Terminated on February 11, 2011
Recall Number Z-1023-2011
Recall Event ID 54658
Premarket Notification
510(K) Number
K091146 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product 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.
Code Information Item Number : 025000. Serial Number: C0150. Model numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.50, and 3.5.1.
Recalling Firm/
Manufacturer
Accuray Inc
1310 Chesapeake Ter
Sunnyvale, California 94089-1100
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Joy M. Sacmar
408-716-4651
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 99 units
Distribution Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = ACCURAY, INC.
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