Medical device recalls Moderate risk

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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