Agency classClass IIOur severity:High FDA (Devices)·Z-0698-2019·Announced 2019-01-16

Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to a risk of detachment of the Compact Gantry Rolling Floor.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that poses a risk of harm (detachment of a floor component) but does not meet the criteria for Severe (no reported injuries or hospitalizations) or Critical (no deaths).

Plain-English summary

Ion Beam Applications S.A. is recalling seven units of the Proteus 235 Proton Therapy System (brand names: Proteus Plus and Proteus ONE). The recall is due to a risk of detachment of the Compact Gantry Rolling Floor.

The affected devices are medical systems 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 systems may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

The recall covers units distributed worldwide, including in the United States (specifically Louisiana and Michigan) and in France, Japan, and the United Kingdom. Affected serial numbers include SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, and SBF.109. Healthcare facilities should contact the manufacturer for further instructions on how to address the defect.

The recalled product

Product: Proteus 235 Product Usage: 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…
Manufacturer: Ion Beam Applications S.A.
Category: Medical Device — Radiation Therapy Equipment
Hazard: structural-defect
fall-hazard
Affected units: 7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

SAT.123
SBF.101
SBF.103
SBF.104
SBF.105
SBF.107
SBF.109

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Ion Beam Applications S.A.

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