medical Class II Updated 2022-06-08

Ion Beam Applications S.A. recalls Proteus235- Proton Therapy System: to produce and deliver a

Recalled Product

Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation


Hazard / Issue

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US), PAT112 (US), SAT116 (US). PAT107 (EU).
View official government recall

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