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Interventional Fluoroscopic X-Ray System

FDA product code OWB · Class 2 · Radiology

702
Registered devices
50,677
Adverse events
625
Recalls
325
510(k) clearances

Devices with this code

TrackX — TrackX Technology, LLCPULSE — Nuvasive, Inc.O-ARM® — MEDTRONIC NAVIGATION, INC.PULSE — Nuvasive, Inc.NA — ECOTRONPULSE — Nuvasive, Inc.ARTIS icono floor — Siemens Healthcare GmbHGenoray — GENORAY CO., LTD.PULSE — Nuvasive, Inc.InfiMed i5, DSA, CCD Camera — INFIMED, INC.O-ARM® — MEDTRONIC NAVIGATION, INC.Azurion — Philips Medical Systems Nederland B.V.PULSE — Nuvasive, Inc.Azurion — Philips Medical Systems Nederland B.V.MC2 App — OXOS Medical, Inc.Interventional Fluoroscopic Mobile X-ray System — GEMSS MEDICAL SYSTEMS CO.,LTD.DISCOVERY — GE MEDICAL SYSTEMSIntelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/STrinias — SHIMADZU CORPORATIONTrinias — SHIMADZU CORPORATIONOEC — GE Hualun Medical Systems Co., LtdLessRay — Nuvasive, Inc.Trinias — SHIMADZU CORPORATIONTrackX — TrackX Technology, LLC

Recent recalls

DateFirmReason
2026-08-26Canon Medical System, USA, INC.Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and
2026-08-04Canon Medical System, USA, INC.Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
2026-07-16PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complicati
2026-07-16PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedu
2026-06-29PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Firmware issue potentially leading to loss of geometry movements.
2026-06-17PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2026-06-17PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2026-06-17PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
2026-06-11Oxos Medical IncDue to a defective circuit board that overheats
2026-06-08Siemens Medical Solutions USA, IncPotential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the su

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.