FDAApril 20, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

ion beam applicationsionion beam

UPCs

05404013801138

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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