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.
Reported: December 25, 2024 Initiated: November 21, 2024 #Z-0704-2025
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.
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
- 100 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 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.. Recalled by GE OEC Medical Systems, Inc. Units affected: 100 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-0704-2025.
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