Device Recall OEC 9800 Plus

62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030

Radiology Devices

2

No

Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.

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.

Serial number 8S-2339-N.

Radiology Devices

2

No

Nationwide and Germany.

OEC 9800 Plus (Fluorotrak), Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.