Company: Toshiba American Med Sys Inc., Date of Enforcement Report 1/16/2008 Class:ll PRODUCT Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Recall # Z-0305-2008 REASON Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel...Read More

Company: SCC Soft Computer Date of Enforcement Report 1/16/2008 Class:ll PRODUCT Softbank II Software Version 23.1 with database Management System Interface. Report Unique Identifier: 1058332-04/07/2006-011-C, Recall # B-0504-08 REASON Software with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SSCC Soft Computer, Clearwater, FL, by e-mail on May 9, 2005. Firm initiated recall is complete....Read More

Company: Siemens Medical Solutions USA, Inc., Date of Enforcement Report 1/16/2008 Class:ll PRODUCT a) Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N: 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Recall # Z-0297-2008; b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version...Read More