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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71116

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

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Event summary

Timeline bucket
May 11, 2012
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 SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;

Z-1581-2015
Recall number
Z-1581-2015
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Quantity
186 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In some cases, the system is unable to capture a clip or image during a routine scan.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

In some cases, the system is unable to capture a clip or image during a routine scan.

Code information

Model 10433816, software versions VA16C, VA16D and VA16E. Device serial numbers: 400230 400708 400462 400467 400460 400461 400084 451021 400743 400225 450122 400634 400687 400023 400126 400265 400717 400740 400458 400459 400678 400665 450123 400617 400485 400083 400092 451024 400223 400404 450143 400650 400663 400664 400577 400470 400479 400493 400519 400318 400674 400463 400484 400679 400680 400589 400466 400168 400139 400270 400308 400236 400689 400691 450151 400693 400615.

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom.