Elekta, Inc. recalls Elekta Unity, Image-Guided Radiation Therapy System
- Recall date
- December 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2473-2020
- FDA classification
- Class II
- Brand / firm
- Elekta, Inc.
- Sold / distributed
- Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.
Why it was recalled
There have been reports of excessive heating in the MRL Gradient Connection Module.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Elekta Unity, Image-Guided Radiation Therapy System
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