Medical device recalls Moderate risk

Ion Beam Applications S.A. recalls Proteus 235

Recall date
March 9, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1695-2017
FDA classification
Class II
Brand / firm
Ion Beam Applications S.A.
Sold / distributed
Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany

Why it was recalled

The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

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

Get recall alerts

Free email alert whenever Ion Beam Applications S.A. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Ion Beam Applications S.A.