Z-2150-2011

Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1)...

Name: Z-2150-2011 Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1)...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2011-03-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-03-28 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162... on 2011-03-28. The reason FDA records is "The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2150-2011
Status: Terminated
Initiated: 2011-03-28
Posted: 2011-05-06
Terminated: 2011-05-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Siemens Medical Solutions USA, Inc. initiated the recall via phone calls and e-mail on March 28, 2011, to all affected customers, informing them of the affected product and providing instructions on the recall. Three units S/N 250171, 250173, and 250177 were to be removed and shipped back to Siemens. Siemens Service personnel were to be dispatched to the customer sites to perform validated stress test on units S/N 250157, 250162, 250163, 250164, 250166, 250167, and 250169 at customer sites. For questions regarding this recall call 650-694-5993.
Quantity in commerce: 10
Distribution: Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.
Product codes and lots: Serial Numbers Affected: 250171, 250173, 250177, 250157, 250162, 250163, 250164, 250166, 250167 and 250169

Product code IYN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)