FDA-Device2014-06-25Class II
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Elekta, Inc.
Hazard
A bug in the software prevents the iGUIDE software from logging off.
Sold states
Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam
Affected count
224
Manufactured in
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, United States
Products
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1807-2014Don't want to check this manually?
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