Company: ACUSON Sequoia Diagnostic Ultrasound System
Date of Enforcement Report 4/30/2008
Class:ll
PRODUCT
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, a) Material Number 8245875; b) Material Number 8246951;
c) Material Number 8267697; Recall Z-0661-2008
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 then stored or saved to the system hard drive, MOD or a storage device. (This image or clip is known as a secondary capture.). 4) The secondary capture images/clips are subsequently recalled for review and measurements are made. If a measurement is taken on these secondary capture images/clips, an error can occur. The error is 0% if taken in the same axis that calibration was performed, and ranges proportionately up to 9% if the measurement is taken orthogonal or at right angles (90 degrees) to the axis that was used for calibration. If calibration was done on the horizontal axis, then vertical measurements are underestimated. If calibration was done on the vertical axis, then horizontal measurements are overestimated.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
280 units.
DISTRIBUTION
Nationwide and Internationally
