Recall Z-0661-2008 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
| Date | Apr 24, 2008 (initiated Sep 25, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, Italy, Latvia, Netherlands, New Zealand, Romania, Russian Federation, Singapore, Spain, Switzerland, Th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063085 | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Nov 14, 2006 |