Recall Z-0703-2025— GE OEC Medical Systems, Inc
Class II · Ongoing
Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2024-11-21. It names 2 FDA 510(k) clearances: K233669, K203346. 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.. Reason: 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..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-21
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.