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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76713

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

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Event summary

Timeline bucket
February 22, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

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

ARTIS Q, Interventional Fluroscopic x-ray system

Z-1534-2017
Recall number
Z-1534-2017
Initiated
February 22, 2017
Classification
Class II
Status
Terminated
Quantity
264 distributed worldwide (112 in the U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

Code information

Model # 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 Serial # 109033 117012 121061 109080 109074 121006 121013 121040 105007 111005 109016 121062 111002 121082 121011 121039 123008 109066 109067 109068 121053 121054 117001 117023 123003 123011 109084 121014 121051 109011 121004 117021 121018 121036 123013 123014 117029 117006 121012 121049 103013 109015 121019 109057 121010 117034 103008 109038 109040 109034 117020 109029 111003 121015 109064 109009 117018 117030 109058 121016 109050 109076 117026 123022 109007 103001 111000 109071 109072 109075 121020 109090 109041 109039 109060 121047 123023 123024 117024 109088 121027 121069 109032 121009 121056 121057 109021 121034 121008 109048 109020 109036 109043 121058 109047 109031 109027 109028 109010 121071 109069 117014 123010 117009 121023 123015 123016 121041 109044 121037 121046 121072

Distribution pattern

Distributed throughout the United States.

Field note

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