Table, Radiologic

Reports per year

Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 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.

• 2007-11-08TerminatedDevice Design

  Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain

  Design Problems Including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potenti