FDA Device Intelligence
HomeDevice types › KXJ

Table, Radiologic

FDA product code KXJ · Class 2 · Radiology

3,231
Registered devices
418
Adverse events
27
Recalls
31
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-08-06IMRIS Imaging IncThe linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and
2025-02-25Baxter Healthcare CorporationThere is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25Baxter Healthcare CorporationThere is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25Baxter Healthcare CorporationThere is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25Baxter Healthcare CorporationThere is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2025-02-25Baxter Healthcare CorporationThere is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
2021-08-25Deerfield Imaging, Inc.ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2021-08-25Deerfield Imaging, Inc.ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2021-08-25Deerfield Imaging, Inc.ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
2019-11-04Villa Sistemi Medicali S.P.A.An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. Af

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