Company: Shimadzu Medical Systems
Date of Enforcement Report: 9/7/05
Class:II

PRODUCT
C-Vision Angiographic X-Ray System, Model IVS-100, Recall # Z-1420-05

REASON
Fluro exposure stuck open, will not terminate.

CODE
Software versions before 3.0

RECALLING FIRM/MANUFACTURER
Recalling Firm: Shimadzu Medical Systems, Torrance, CA, by letter in April 2002.
Manufacturer: Shimadzu Corporation, Kyoto, Japan. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
24 units

DISTRIBUTION
Nationwide and Canada