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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93293

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

Open FDA event record

Event summary

Timeline bucket
September 18, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

Z-0295-2024
Recall number
Z-0295-2024
Initiated
September 18, 2023
Classification
Class II
Status
Ongoing
Quantity
5 (US), 9 (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

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

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Code information

UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.

Distribution pattern

Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.

Field note

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