Recall Z-0930-2013 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
| Date | Mar 9, 2013 (initiated Jan 18, 2013) |
| Status | Terminated |
| Reason | On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 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, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Port |
| 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 |