Recall Z-1063-2015 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
| Date | Feb 7, 2015 (initiated Jan 12, 2015) |
| Status | Terminated |
| Reason | There is a low probability the scanner arm will become completely detached from the scanner column. |
| Root cause | Vendor change control |
| Action | Siemens sent a Customer Safety Advisory Notification to all affected sites on January 12, 2015, certified mail, with return receipt. The letter identified the affected product, the issue, and potential risk. Customers were asked to immediately discontinue use of the affected product. A Customer Service Engineer will contact customers to schedule an appointment to make the necessary repairs. Questions should be directed to a local service support person for information regarding timelines and status. Customers are to share the information with all personnel, who need to be aware of the iss |
| Quantity | 24 units |
| Distribution | Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy. |
| 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 |