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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89267

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

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Event summary

Timeline bucket
November 29, 2021
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; Version: PTS-8 versions before PTS-8.7.2

Z-0466-2022
Recall number
Z-0466-2022
Initiated
November 29, 2021
Classification
Class II
Status
Terminated
Quantity
5 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software can

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

Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.

Code information

PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).

Distribution pattern

IN USA: VA, OK, NJ, TN OUS: Czech Republic.