medical Class II Updated 2021-08-04

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

Recalled Product

Proteus 235-Proton Therapy System

Hazard / Issue

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

Issued by

FDA

Affected States: FL, PA, TN, TX, VA
Lot/Code Info: Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
View official government recall

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