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FDADecember 13, 2016device

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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. The PTS may include a fixed s...

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

The hazard

Software issue

What to do

FDA enforcement status: Terminated

Brands named

ion beam applicationsionion beam

Recall history

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

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Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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. The PTS may include a fixed s... — Recall Details · AllClear