Elekta, Inc. recalls Focal Sim radiation therapy treatment planning system
- Recall date
- December 19, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1244-2015
- FDA classification
- Class II
- Brand / firm
- Elekta, Inc.
- Sold / distributed
- Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germa…
Why it was recalled
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Focal Sim radiation therapy treatment planning system
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