ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 -
FDA device recall Z-1063-2015 · posted 2015-02-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- There is a low probability the scanner arm will become completely detached from the scanner column.
- Action taken
- 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 issue.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 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.
- Date initiated
- 2015-01-12
- Date posted
- 2015-02-07
- Date terminated
- 2015-06-10
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |