medical Class II Updated 2020-08-05

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

Recalled Product

Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed 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

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

Issued by

FDA

Affected States: VA
Lot/Code Info: Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
View official government recall

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