Elekta, Inc. recalls iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a…
- Recall date
- June 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3017-2017
- FDA classification
- Class II
- Brand / firm
- Elekta, Inc.
- Sold / distributed
- 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…
Why it was recalled
Incorrect PEC values.
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 Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
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