Ultrasound Cl II Toshiba American Med Sys Inc

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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.