Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom
FDA device recall Z-2150-2011 · posted 2011-05-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 10
- Distribution
- Worldwide Distribution - USA, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia.
- Date initiated
- 2011-03-28
- Date posted
- 2011-05-06
- Date terminated
- 2011-05-06
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER (K081148) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-12-22 |