ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road M
FDA device recall Z-0825-2014 · posted 2014-01-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- The locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel, making it unable to steer or control during transport.
- Action taken
- Customer Safety Advisory Letters were sent to all affected users on December 22, 2013. Letters advised of the issues and the actions they should take until a Siemens Field Engineer will visit and upgrade the control panel.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 271 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Canada, Ecuador, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Mexico, P.R. China, Philippines, Portu
- Date initiated
- 2013-12-22
- Date posted
- 2014-01-24
- Date terminated
- 2015-03-05
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON (K123622) | Siemens Medical Solutions USA, Inc. | 2012-12-05 |