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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66315

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

Open FDA event record

Event summary

Timeline bucket
August 28, 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 RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system

Z-1845-2014
Recall number
Z-1845-2014
Initiated
August 28, 2013
Classification
Class II
Status
Terminated
Quantity
76

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software versions VD10A/G during a RAD examination, a malfunction

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

When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.

Code information

Model numbers 10094910, 10281013, and 10281163 with software version VB10G.

Distribution pattern

USA Nationwide Distribution in the states of OH, NJ, MA, CO, NY, CA, MD, OR, KY, PA, IL, VA, TX, MN, KS, GA, and WY.