Company:GE OEC Medical Systems, Inc
Date of Enforcement Report 8/8/12
Class ll:
PRODUCT
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.
Recall Number Z-2125-2012
REASON
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT on 3/23/2007. FDA Mandated recall has been terminated.
VOLUME OF PRODUCT IN COMMERCE
Part of a total of 82 units distributed
DISTRIBUTION
Worldwide Distribution – US (nationwide) and the countries of: Canada, France, Japan, and China.
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