Recall Z-2150-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
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 (
| Date | May 6, 2011 (initiated Mar 28, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 10 |
| Distribution | Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081148 | SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER Siemens Medical Solutions USA, Inc., Ultrasound DI, Dec 22, 2008 |