FDA-Device2019-08-21Class II
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Elekta, Inc.
Hazard
Potential for iGUIDE to incorrectly monitor the 3D position.
Sold states
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.
Affected count
374 devices
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2230-2019Don't want to check this manually?
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