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GE OEC Medical Systems, Inc recalls OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is de
Recalled December 25, 2024 · FDA recall Z-0705-2025 · GE OEC Medical Systems
Hazard
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. · FDA Class II
Units
78 systems
Sold at
U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom
Description
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Product
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →