FDAFDA · Food and drugs·Recall number Z-0930-2013
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
Published March 20, 2013 · Recall initiated: January 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Distributor
- Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela.
- Lot
- Model number 10042541 - AVBS module. Note: the S2000 system part number is 10041461, however only those systems that include the ABVS module, part number 10042541 are affected. Manufactured prior to 10/30/2012.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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