Company: GE OEC Medical Systems, Inc.
Date of Enforcement Report:10/11/2006
Class:ll
PRODUCT
a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, Recall # Z-1301-06;
b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06;
c) RUS Tool Version Software, Recall # Z-1303-06
REASON
X-ray systems could provide output which exceeds the 20 R/minute limit.
CODE
a), and b) All units;
c) All versions prior to Version 7.1.43
RECALLING FIRM/MANUFACTURER
RGE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 14-15, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
11,279 units
DISTRIBUTION
Nationwide and Internationally
