Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 3/31//2010
Class:ll
PRODUCT
1) Aplio 50; SSA-700A; software version 5.5r002. Recall # Z-1171-2010;
2) Aplio 80; SSA-770A; software version 5.5r002. Z-1172-2010;
3) Xario; SSA-660A; software version 1.0 and later. Recall # Z-1173-2010
REASON
Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin CA, by letter on November 12, 2007.
Manufacturer: Toshiba Electron Tubes & Devices Co., Ltd., Otawa-Shi, Tochigi, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
Nationwide
