—#99480

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K081148
Affected lot / code info: Serial Numbers Affected: 250171, 250173, 250177, 250157, 250162, 250163, 250164, 250166, 250167 and 250169

Why it was recalled

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 (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.

Timeline

Recall initiated: 2011-03-28
Posted by FDA: 2011-05-06
Terminated: 2011-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.