Medical device recalls Moderate risk

Ion Beam Applications S.A. recalls Proteus 235, Proton Therapy System

Recall date
March 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1830-2017
FDA classification
Class II
Brand / firm
Ion Beam Applications S.A.
Sold / distributed
Distribution in US (to Louisiana), and France.

Why it was recalled

In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Proteus 235, Proton Therapy System

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