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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64231
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc.
City Mountain View
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-18
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. 214 affected devices Z-0930-2013
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