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Elekta, Inc. recalls iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the
Recalled June 25, 2014 · FDA recall Z-1807-2014 · Elekta
Hazard
A bug in the software prevents the iGUIDE software from logging off. · FDA Class II
Units
224
Sold at
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
Description
A bug in the software prevents the iGUIDE software from logging off.
Product
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.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →