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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65795

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

Open FDA event record

Event summary

Timeline bucket
January 21, 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

Artis zee systems x-ray, angiographic system

Z-0172-2014
Recall number
Z-0172-2014
Initiated
January 21, 2013
Classification
Class II
Status
Terminated
Quantity
17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.

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

The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.

Code information

model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot

Distribution pattern

US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.