Medical device recalls Moderate risk

Ion Beam Applications S.A. recalls Proteus 235 and Proteus ONE proton therapy systems

Recall date
May 18, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2672-2017
FDA classification
Class II
Brand / firm
Ion Beam Applications S.A.
Sold / distributed
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

Why it was recalled

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

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 and Proteus ONE proton therapy systems

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