Ge Oec Medical Systems, Inc.
Ge Oec Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2024, with 48 FDA device recalls on record.
Top product codes for Ge Oec Medical Systems, Inc.
FDA recalls by Ge Oec Medical Systems, Inc.
10 most recent of 48- Z-0704-2025 — 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.
- Z-0705-2025 — OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Z-0706-2025 — OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
- Z-0703-2025 — 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.
- Z-2277-2023 — OEC 9900 Systems with 9-inch Image Intensifier
- Z-2275-2023 — OEC Flexiview 8800 Systems with 9-inch Image Intensifier
- Z-2279-2023 — Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems
- Z-2278-2023 — OEC Elite Systems with 9-inch Image Intensifier
- Z-2276-2023 — OEC 9800 Systems with 9-inch Image Intensifier
- Z-2161-2021 — OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ge Oec Medical Systems, Inc.
- K233669 — OEC 3D
- K203346 — OEC 3D
- K192819 — OEC Elite
- K172550 — OEC Elite
- K171565 — OEC Elite
- K132027 — OEC 9800 PLUS
- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- K051490 — GE OEC EVERVIEW 7500
- K043076 — GE OEC FLUOROSTAR
- K041931 — OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
- K041932 — OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.