Company:Fischer Imaging Corporation,
Date of Enforcement Report:4/19/2006
Class:lI
PRODUCT
SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06
REASON
Software upgrade to preclude lost images during mammography procedure.
CODE
Software versions earlier than 5.2.2
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
80 units ,p>
DISTRIBUTION
Nationwide
