GE OEC Medical Systems, Inc recalls OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging sy

Recalled December 25, 2024 · FDA recall Z-0703-2025 · 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

84 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 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

Manufacturer(s)

GE OEC Medical Systems, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →