Z-1063-2015Class II

ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are...

Name: Z-1063-2015 ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2015-01-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-01-12 / Terminated / root cause: supplier

FDA source

Siemens Medical Solutions USA, Inc. began a recall of ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm... on 2015-01-12. FDA classified it as Class II and gives the reason as "There is a low probability the scanner arm will become completely detached from the scanner column". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1063-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-12
Posted: 2015-02-07
Terminated: 2015-06-10
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: There is a low probability the scanner arm will become completely detached from the scanner column.
Root cause tag: supplier
FDA root cause: 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.
Product codes and lots: Serial numbers 250157-250190.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1063-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1063-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-07

Product code IYO

K081148Class IISiemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI / cleared 2008-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)