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Elekta, Inc. recalls iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Recalled August 21, 2019 · FDA recall Z-2230-2019 · Elekta
Hazard
Potential for iGUIDE to incorrectly monitor the 3D position. · FDA Class II
Units
374 devices
Sold at
Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
Description
Potential for iGUIDE to incorrectly monitor the 3D position.
Product
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →