Exact FDA event identifier

Event 79228

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 19, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Ion Beam Applications S.A.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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. The PTS 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.

Z-0931-2018

Recall number: Z-0931-2018
Initiated: October 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Ion Beam Applications S.A.
Quantity: 3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

Code information

PAT.003 (KR), PAT.006 (US)

Distribution pattern

US Distribution to the state of :FL