ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA
FDA device recall Z-0930-2013 · posted 2013-03-09 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
- Action taken
- Siemens sent a Customer Safety Advisory notification letter to Siemens Service Personnel on January 18, 2013 and which would be provided to all affected sites during their visit to correct the problem. The notification identified the product, the problem and the action to be taken. The local Customer Service Engineer will perform the test at their site. If the system passes the test, no further action is required. If the ABVS pod fails the inspection, the Service Engineer will correct the sharp edge. For questions regarding this recall call 650-694-5398.
- Root cause
- Process design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 214 affected devices
- Distribution
- Worldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan
- Date initiated
- 2013-01-18
- Date posted
- 2013-03-09
- Date terminated
- 2013-07-16
- 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 |