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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80417

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

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Event summary

Timeline bucket
May 30, 2018
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 Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Z-2524-2018
Recall number
Z-2524-2018
Initiated
May 30, 2018
Classification
Class II
Status
Terminated
Quantity
40 in the United States

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

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

During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

Code information

164033, 164071, 164034, 164095, 164057, 164054, 164055, 164080, 164072, 164088, 164048, 164094, 164068, 164019, 164013, 164073, 164025, 164026, 164027, 164060, 164083, 164021, 164066, 164075, 164074, 164084, 164086, 164098, 164028, 164053, 164063, 164064, 164024, 164049, 164018, 164022, 164061, 164100, 164097, 164011

Distribution pattern

The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.