Elekta, Inc. recalls iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
- Recall date
- June 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2230-2019
- FDA classification
- Class II
- Brand / firm
- Elekta, Inc.
- Sold / distributed
- 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 R…
Why it was recalled
Potential for iGUIDE to incorrectly monitor the 3D position.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
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