Recall – Cl ll Accuray Radiation therapy device

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

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. Item Number: 025000. Recall # Z-1023-2011.

REASON
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.

RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by letter dated January 18, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
99 units

DISTRIBUTION
Nationwide and Internationally

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