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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON S2000

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  Class 2 Device Recall ACUSON S2000 see related information
Date Initiated by Firm January 12, 2015
Date Posted February 07, 2015
Recall Status1 Terminated 3 on June 10, 2015
Recall Number Z-1063-2015
Recall Event ID 70361
510(K)Number K081148  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730.
The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding.

The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
Code Information Serial numbers 250157-250190.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
685 E Middlefield Rd
Mountain View CA 94043-4045
For Additional Information Contact Sheila Pickering, Ph.D.
650-694-5135
Manufacturer Reason
for Recall		 There is a low probability the scanner arm will become completely detached from the scanner column.
FDA Determined
Cause 2		 Vendor change control
Action Siemens sent a Customer Safety Advisory Notification to all affected sites on January 12, 2015, certified mail, with return receipt. The letter identified the affected product, the issue, and potential risk. Customers were asked to immediately discontinue use of the affected product. A Customer Service Engineer will contact customers to schedule an appointment to make the necessary repairs. Questions should be directed to a local service support person for information regarding timelines and status. Customers are to share the information with all personnel, who need to be aware of the issue.
Quantity in Commerce 24 units
Distribution Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.
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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