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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81807

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

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Event summary

Timeline bucket
December 12, 2018
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 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 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-0698-2019
Recall number
Z-0698-2019
Initiated
December 12, 2018
Classification
Class II
Status
Terminated
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a risk of detachment of the Compact Gantry Rolling Floor.

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

There is a risk of detachment of the Compact Gantry Rolling Floor.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.