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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67016

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

Open FDA event record

Event summary

Timeline bucket
December 05, 2013
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

Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray

Z-1202-2014
Recall number
Z-1202-2014
Initiated
December 05, 2013
Classification
Class II
Status
Terminated
Quantity
19

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

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

There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40).

Code information

model numbers 10848280, 10848281, 10848282, and 10848283.

Distribution pattern

USA Nationwide Distribution in the states of TN, MA, CA, IL, OH, FL, UT, WA, GA, IA, NY, MO, IN, and CO.