Company: Toshiba American Med Sys Inc
Date of Enforcement Report:11/21/2007
Class:ll

PRODUCT
a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B,
V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0,
V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008;
b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0,
Vl .5.000A, VI .5.000B, V2.0.0, Recall # Z-0254-2008

REASON
Multiple problems including: (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on August 29, 2007.
Manufacturer: Matsushita Electric Industrial Co., Ltd. – Med. Sys. Division, Yokohama City, Kanagawa, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,406 units

DISTRIBUTION
Nationwide