Home › Device types › OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA product code OXO · Class 2 · Radiology
154
Registered devices
10,986
Adverse events
49
Recalls
82
510(k) clearances
Devices with this code
Ziehm Solo FD — Ziehm Imaging GmbHDISCOVERY — GE MEDICAL SYSTEMSAllia — GE MEDICAL SYSTEMSO-arm O2 — MEDTRONIC NAVIGATION, INC.Genoray — GENORAY CO., LTD.SURGIVISIO DEVICE — ECENTIAL ROBOTICSOEC — GE Hualun Medical Systems Co., LtdAMRAD Medical — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOEC — OEC MEDICAL SYSTEMS, INC.TAU Model 1000-0016 Mini C-Arm — Ziehm-Orthoscan, Inc.Broach Set SPX1 — ECENTIAL ROBOTICSNA — ECOTRONFoot Pedal — OXOS Medical, Inc.Zenition 90 — Philips Medical Systems Nederland B.V.Veradius — Philips Medical Systems Nederland B.V.3D Imaging Set SPX1 — ECENTIAL ROBOTICSOEC — GE Hualun Medical Systems Co., LtdAllia — GE MEDICAL SYSTEMSOEC — GE Hualun Medical Systems Co., LtdOEC — GE Hualun Medical Systems Co., LtdAMRAD Medical — A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOEC — OEC MEDICAL SYSTEMS, INC.BV Endura — Philips Medical Systems Nederland B.V.Zenition — Philips Medical Systems Nederland B.V.
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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