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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80222

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

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Event summary

Timeline bucket
August 07, 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

Proteus 235 The PTS 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-2173-2018
Recall number
Z-2173-2018
Initiated
August 07, 2016
Classification
Class II
Status
Terminated
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

Code information

Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126.

Distribution pattern

Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.

Field note

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