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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70361

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

Open FDA event record

Event summary

Timeline bucket
January 12, 2015
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

ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

Z-1063-2015
Recall number
Z-1063-2015
Initiated
January 12, 2015
Classification
Class II
Status
Terminated
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a low probability the scanner arm will become completely detached from the scanner column.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a low probability the scanner arm will become completely detached from the scanner column.

Code information

Serial numbers 250157-250190.

Distribution pattern

Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.

Field note

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