Company: Toshiba America Medical Systems, Inc.,
Date of Enforcement Report:3/8/2006
Class:Il
PRODUCT
Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06
REASON
Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use.
CODE
Serial numbers D4622390, D4622394, D4623349, D4612382, D5512402.
RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, CA, by software installation beginning on February 22, 2006. Firm initiated recall is on going.
VOLUME OF PRODUCT IN COMMERCE
5 systems
DISTRIBUTION
Nationwide
