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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65491

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

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Event summary

Timeline bucket
May 07, 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 Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

Z-1848-2013
Recall number
Z-1848-2013
Initiated
May 07, 2013
Classification
Class II
Status
Terminated
Quantity
4

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version VD10A. The possibility exists that a software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.

Code information

Model number 10094200, serial numbers 4024, 4077, 4043 and 4051

Distribution pattern

US Distribution including the states of CA, IN, NJ and OK.