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Elekta, Inc. recalls iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System
Recalled August 16, 2017 · FDA recall Z-3017-2017 · Elekta
Hazard
Incorrect PEC values. · FDA Class II
Units
110 units
Sold at
Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, & Vietnam.
Description
Incorrect PEC values.
Product
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with 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 →