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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68027

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

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Event summary

Timeline bucket
April 02, 2014
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 ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.

Z-1504-2014
Recall number
Z-1504-2014
Initiated
April 02, 2014
Classification
Class II
Status
Terminated
Quantity
490

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study, data from the previous patient could replace the current patient's date in the report.

Code information

Model numbers: 1065844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea)

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Brunei, Chile, Colombia, Croatia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Liechtenstein, Malaysia, Mauritius, Montenegro, Namibia, Nepal, Nigeria, Norway, Palestinian Ter, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Turkmenistan, U.A.E., United Kingdom.