|
PRODUCT
1) Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. Generating head and whole body CT images of human subjects. Recall # Z-0494-2010;
2) Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. Generating head and whole body CT images of human subjects. Recall # Z-0495-2010;
3) Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. Generating head and whole body CT images of human subjects. Recall #Z-0496-2010
CODE
All serial numbers associated with the above model numbers.
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by letter February 2010. Firm initiated recall is ongoing.
REASON
Failure to provide the complete User Manual information.
VOLUME OF PRODUCT IN COMMERCE
343 units
DISTRIBUTION
Nationwide |
