Home › Device types › OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA product code OXO · Class 2 · Radiology
162
Registered devices
10,999
Adverse events
49
Recalls
82
510(k) clearances
Devices with this code
O-ARM® — MEDTRONIC NAVIGATION, INC.NA — ECOTRONGenoray — GENORAY CO., LTD.O-ARM® — MEDTRONIC NAVIGATION, INC.MC2 App — OXOS Medical, Inc.Interventional Fluoroscopic Mobile X-ray System — GEMSS MEDICAL SYSTEMS CO.,LTD.OEC — GE Hualun Medical Systems Co., LtdOEC — GE Hualun Medical Systems Co., LtdSIREMOBIL Compact L — Siemens Healthcare GmbHO-ARM® — MEDTRONIC NAVIGATION, INC.ARCADIS Orbic — Siemens Healthcare GmbHOrthoScan Mobile DI Mini C-arm — Ziehm-Orthoscan, Inc.IGS WF BP — GE MEDICAL SYSTEMSBV Pulsera — Philips Medical Systems Nederland B.V.CIARTIC Move — Siemens Healthcare GmbHSmart-C — TURNER IMAGING SYSTEMSImage-intensified fluoroscopic x-ray system, mobile — GEMSS MEDICAL SYSTEMS CO.,LTD.A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOEC — OEC MEDICAL SYSTEMS, INC.STEPHANIX — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLGenoray — GENORAY CO., LTD.Ziehm 8000 — Ziehm Imaging GmbHTRIDENT — TECHNIX SPATAU Model 1000-0016 Mini C-Arm — Ziehm-Orthoscan, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-21 | GE Medical Systems, LLC | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2025-03-21 | GE Medical Systems, LLC | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| 2024-11-21 | GE OEC Medical Systems, Inc | 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. |
| 2024-11-21 | GE OEC Medical Systems, Inc | 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. |
| 2024-11-21 | GE OEC Medical Systems, Inc | 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. |
| 2024-11-21 | GE OEC Medical Systems, Inc | 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. |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh |
| 2023-05-15 | GE OEC Medical Systems, Inc | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, wh |
| 2021-06-10 | GE OEC Medical Systems, Inc | There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |
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