ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA
FDA device recall Z-0661-2008 · posted 2008-04-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is t
- Action taken
- Consignees were notified via a Urgent Medical Device Notification letter/customer letter sent out on 9/25/2007 under Siemens update program US013/07/S. The Siemens Service organization coordinates the implementation of the field correction with the distributors for all countries. Consignees who do not respond to the recall communication will be visit ed and/or telephoned for follow up.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 280
- Distribution
- Worldwide Distribution including the countries of: Australia, Austria, Belgium, Brazil, Brunei, China, Denmark, Finland, France, Germany, Great Britain (UK), Greece, Hungary, India, Iran, Ireland, Ita
- Date initiated
- 2007-09-25
- Date posted
- 2008-04-24
- Date terminated
- 2010-12-20
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM (K063085) | Siemens Medical Solutions USA, Inc. | 2006-11-14 |