Company:Toshiba Medical Systems Co.
Date of Enforcement Report 10/7/2009
Class:ll

PRODUCT
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall # Z-0005-2009

REASON
Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on September 30, 2008.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
129 units

DISTRIBUTION
Nationwide