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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94576

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

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Event summary

Timeline bucket
May 10, 2024
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 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Z-1945-2024
Recall number
Z-1945-2024
Initiated
May 10, 2024
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

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

Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

Code information

UDI: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator

Distribution pattern

Worldwide - US Nationwide distribution in the state of Virginia and the country of India.