Home › Device types › OWB
Interventional Fluoroscopic X-Ray System
FDA product code OWB · Class 2 · Radiology
685
Registered devices
49,979
Adverse events
624
Recalls
323
510(k) clearances
Devices with this code
Azurion — Philips Medical Systems Nederland B.V.ImagingRing m — medPhoton GmbHMULTIPURPOSE REMOTE CONTROL R/F SYSTEM — CANON INC.STEPHANIX — STEPHANIXZiehm Solo FD — Ziehm Imaging GmbHPULSE — Nuvasive, Inc.TrackX — TrackX Technology, LLCLessRay — Nuvasive, Inc.InfiMed Nexus, RF/DR, Non Varian Digital Receptor — INFIMED, INC.PULSE — Nuvasive, Inc.Trinias — SHIMADZU CORPORATIONPULSE — Nuvasive, Inc.LessRay — Nuvasive, Inc.Trinias — SHIMADZU CORPORATIONPULSE — Nuvasive, Inc.PULSE — Nuvasive, Inc.Trinias — SHIMADZU CORPORATIONLessRay — Nuvasive, Inc.DISCOVERY — GE MEDICAL SYSTEMSAllia — GE MEDICAL SYSTEMSPULSE — Nuvasive, Inc.SmartCT — Philips Medical Systems Nederland B.V.Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/SPULSE — Nuvasive, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-04 | Canon 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. |
| 2026-07-16 | PHILIPS 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 |
| 2026-07-16 | PHILIPS 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 |
| 2026-06-29 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Firmware issue potentially leading to loss of geometry movements. |
| 2026-06-17 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 2026-06-17 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 2026-06-17 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. |
| 2026-06-11 | Oxos Medical Inc | Due to a defective circuit board that overheats |
| 2026-06-08 | Siemens Medical Solutions USA, Inc | Potential 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 |
| 2026-05-20 | Siemens Medical Solutions USA, Inc | Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits. |
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