GE OEC Medical Systems, Inc: Device Recall

Recall #Z-0704-2025 · 11/21/2024

Class II: Risk

Recall Details

Recall Number: Z-0704-2025
Classification: Class II
Product Type: Device
Recalling Firm: GE OEC Medical Systems, Inc
Status: Ongoing
Date Initiated: 11/21/2024
Location: Salt Lake City, UT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 100 systems

Reason for Recall

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 Description

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

Distribution Pattern

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

Other Recalls by GE OEC Medical Systems, Inc

Class II: Risk 11/21/2024

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.
Class II: Risk 11/21/2024

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.
Class II: Risk 11/21/2024

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.

View all recalls by GE OEC Medical Systems, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.