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Ion Beam Applications S.A. recalls Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tu
Recalled June 8, 2022 · FDA recall Z-1205-2022 · Ion Beam Applications S.A
Hazard
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 · FDA Class II
Units
4 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.
Description
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
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
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →