Company: Fischer Imaging Corp
Date of Enforcement Report: 7/21/04
Class: II
PRODUCT
Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04.
REASON
Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
CODE
Product number 94829G-1, 94830G-1, 94830G-2.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corp, Denver, CO, by telephone and letter on May 21, 2004. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
FL, NC, NY, OK, WI, and France.
