Company:Toshiba American Med Sys Inc
Date of Enforcement Report: 12/22/04
Class: II
PRODUCT
Magnetic Resonance Imaging Systems under the following names: Visart, Excelart, Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE. Recall # Z-0270-05.
REASON
Software defect causes images to be rotated 180 degrees.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc., Tustin, CA, by letter on October 6, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide.
