Cl ll CyberKnife Treatment Planning System

Company: Accuray Inc.
Date of Enforcement Report 2/9/2011
Class ll:

PRODUCT
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. Recall # Z-1008-2011.

REASON
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.

RECALLING FIRM/MANUFACTURER
Accuray Inc, Sunnyvale, CA, by letter dated December 29, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
71

DISTRIBUTION
Nationwide and Internationally

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.