Company:Toshiba America Medical Systems, Inc.,
Date of Enforcement Report:12/5/2007
Class:ll

PRODUCT
Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008

REASON
System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error..

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba America Medical Systems, Inc., Tustine, CA, by letters beginning on October 2, 2007.
Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Otawara-Shi, Tochigi, Japan. Firm initiated recall is ongoing. .

VOLUME OF PRODUCT IN COMMERCE
23 units

DISTRIBUTION
Nationwide