Elekta, Inc. recalls Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiat…
- Recall date
- June 1, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1719-2015
- FDA classification
- Class II
- Brand / firm
- Elekta, Inc.
- Sold / distributed
- Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
Why it was recalled
Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
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