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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON S2000 Automated Breast Volume Scanner (ABVS);

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  Class 2 Device Recall ACUSON S2000 Automated Breast Volume Scanner (ABVS); see related information
Date Initiated by Firm January 18, 2013
Date Posted March 09, 2013
Recall Status1 Terminated 3 on July 16, 2013
Recall Number Z-0930-2013
Recall Event ID 64231
510(K)Number K081148  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Sheila Pickering
650-694-5398
Manufacturer Reason
for Recall		 On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
FDA Determined
Cause 2		 Process design
Action Siemens sent a Customer Safety Advisory notification letter to Siemens Service Personnel on January 18, 2013 and which would be provided to all affected sites during their visit to correct the problem. The notification identified the product, the problem and the action to be taken. The local Customer Service Engineer will perform the test at their site. If the system passes the test, no further action is required. If the ABVS pod fails the inspection, the Service Engineer will correct the sharp edge. For questions regarding this recall call 650-694-5398.
Quantity in Commerce 214 affected devices
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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