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.
Reported: December 25, 2024 Initiated: November 21, 2024 #Z-0703-2025
Product Description
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.
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.
Details
- Recalling Firm
- GE OEC Medical Systems, Inc
- Units Affected
- 84 systems
- Distribution
- 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
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GE OEC Medical Systems, Inc. Units affected: 84 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2024. Severity: Moderate. Recall number: Z-0703-2025.
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