Accuray Inc

Software Versions 1.6, 1.6.1, 1.6.3, 2.0, 2.0.1, and below.

Radiology Devices

2

No

Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey.

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.

All units that have MP software version 3.0 and the Iris Collimator in clinical use at the same time are subject to this recall.

Radiology Devices

2

No

Nationwide Distribution. Product was distributed to 4 medical facilities in the US.

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.

All units of these models.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan

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.

All units of these models.

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan

CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA || A Radiation therapy device.

All system Serial Numbers C128 and higher with 2005 edition Robot Controller.

Radiology Devices

2

No

Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.

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.