Table, Radiologic
FDA adverse event reports and recall history for table, radiologic (product code KXJ), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 418
- Deaths
- 7
- Injuries
- 68
- Malfunctions
- 307
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-26Open, ClassifiedNonconforming Material/Component
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
- 2025-03-21Open, ClassifiedSoftware design
Baxter Mobile column TruSystem 7500 U, Product Code 1730720
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-03-21Open, ClassifiedSoftware design
Baxter Stationary column TruSystem 7500 U, Product Code 1730731
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-03-21Open, ClassifiedSoftware design
Baxter Floor mounting column TS 7500 U, Product Code 1730732
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-03-21Open, ClassifiedSoftware design
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-03-21Open, ClassifiedSoftware design
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2019-06-10TerminatedDevice Design
Prestilix 1600X Prestilix system is a fully integrated remote controlled digital radiology system. It is designed for all general radiology applications with or without contract injection and interventional procedures.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
- 2015-03-06TerminatedRadiation Control for Health and Safety Act
Juno DFR X-ray system
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
- 2013-09-13TerminatedRadiation Control for Health and Safety Act
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
- 2011-05-23TerminatedDevice Design
Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market) The carbon-fibre MAGNUS table top serves to support and position patients for surgical procedures and interventional examination immediately before, during and after the surgical phase. The table top is radio translucent and enables intra-operative use of x-ray equipment.
Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.
Monitor table, radiologic automatically
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