Recall Z-1107-2004 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039
| Date | Feb 15, 2008 (initiated Sep 18, 2007) |
| Status | Terminated |
| Reason | Software error: Error affects all Aspen customer systems using the PAL video standard configuration and have a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reco |
| Root cause | Software design |
| Action | Siemens issued an Urgent Medical Device Notification to consignees 9/18/07, under Siemens update program US014/07/S. (Distribution on this product had ceased on 6/29/2005.) The firm has instructed the user to not take measurements or use measurements on these secondary captures under the conditions described in the notice, to place a copy of the instructions for use in the file, and to notify all users of the issue with the software. The Siemens Service organization has coordinated the implementation of the field correction with the distributors for all countries. Non-responding consignees |
| Quantity | 280 units |
| Distribution | Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain (UK), Greece, Hong Kong, India, Italy, Jordan, Malaysia, Norway, Poland, Portugal, Romania, Russian Federation, Sweden, Swit |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION Acuson Corp., Aug 2, 1999 |