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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80217

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

Open FDA event record

Event summary

Timeline bucket
April 11, 2016
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

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

Z-2284-2018
Recall number
Z-2284-2018
Initiated
April 11, 2016
Classification
Class II
Status
Terminated
Quantity
2

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue and to reduce the risk related to this issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

Code information

PAT.003 and PAT.006

Distribution pattern

Units were distributed to Korea and Jacksonville, FL.