Table, Radiologic
Radiology · 21 CFR 892.1980
Recent MDR events
418 adverse event reports on file
- HYDRA VISIONDec 17, 2025MalfunctionDel Medical0001418964-2025-00002
- MAGNUS CARBON FIBRE TABLE TOPOct 28, 2025MalfunctionMaquet Gmbh8010652-2025-0000037
- ORT200 TABLEOct 24, 2025MalfunctionImris Imaging, Inc.3010326005-2025-00003
- PST500Jun 17, 2025MalfunctionBaxter Healthcare Corporation3007143268-2025-00047
- PST 500Jun 5, 2025MalfunctionBaxter Healthcare Corporation3007143268-2025-00042
- PST 500Jun 5, 2025MalfunctionBaxter Healthcare Corporation3007143268-2025-00043
- PST 500May 28, 2025MalfunctionBaxter Healthcare Corporation3007143268-2025-00041
- MAGNUSJan 28, 2025MalfunctionMaquet Gmbh8010652-2025-0000003
- IMRIS ORT300 OPERATING ROOM TABLEJan 17, 2025MalfunctionImris - Deerfield Imaging, Inc.3010326005-2025-00002
- IMRIS ORT200 OPERATING ROOM TABLEDec 21, 2024MalfunctionImris - Deerfield Imaging, Inc.3010326005-2024-00016
Event type breakdown
Recalls
26 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
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.
Z-1413-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
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.
Z-1414-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
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.
Z-1415-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
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.
Z-1416-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedMar 21, 2025
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.
Z-1420-2025 · View FDA record ↗ - GE Healthcare, LLCTerminatedJun 10, 2019
Prestilix 1600X
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
Z-1753-2019 · View FDA record ↗ - Villa Radiology Systems LLCTerminatedMar 6, 2015
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
Z-1079-2015 · View FDA record ↗ - Villa Radiology Systems LLCTerminatedSep 13, 2013
Juno DRF System. Mobile X-ray system
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
Z-2160-2013 · View FDA record ↗ - Maquet Inc.TerminatedMay 23, 2011
Maquet Magnus Carbon-fibre table top; Device Part Number 1180.16xx (x represents a digit from 0-5 and F-for the US market)
Maquet GmbH's quality monitoring detected that incorrect cover sheets were installed with some Magnus carbon fibre table tops.
Z-2238-2011 · View FDA record ↗ - GE HealthcareTerminatedNov 8, 2007
Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145,
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
Z-0075-2008 · View FDA record ↗
Registered firms
33 firms currently registered for this product code
Gabriel Scientific Ou
Parnu linn Parnumaa, EE
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Philips Electronics Ltd
Mississauga Ontario, CA
Mizuho Orthopedic Systems, Inc.
UNION CITY, CA, US
Ge Medical Systems Monterrey Mexico, S.a. De C.v.
APODACA Nuevo Leon, MX
Ge Medical Systems, Llc
WAUKESHA, WI, US
Surgical Tables Incorporated
MIDDLETON, MA, US
Ge Healthcare (china) Co., Ltd.
Beijing, CN
Umi Intl.
Norwood, NJ, US
Maquet Gmbh
RASTATT Baden-Wurttemberg, DE
Orfit Industries Nv
WIJNEGEM Antwerpen, BE
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Anholt Technologies Inc.
Avondale, PA, US
Ecotron Co., Ltd.
Seoul, KR
Imris Imaging, Inc.
Chaska, MN, US
Domico Med-device, Llc
Fenton, MI, US
Baxter Medical Systems Gmbh + Co. Kg
SAALFELD Thuringia, DE
General Medical Merate S.p.a.
SERIATE, BERGAMO, IT
Livermoretech,inc
Plano, TX, US
Getinge Ab
POZNAN Wielkopolskie, PL
Villa Sistemi Medicali S.p.a.
BUCCINASCO Milano, IT
Siemens Healthineers Ag
KEMNATH Bavaria, DE
Del Medical, Inc.
Bloomingdale, IL, US
Carestream Health, Inc., Global R&d Center
SHANGHAI, CN
510(k) clearances
31 clearances for this product code
- Villa Sistemi Medicali S.P.A.Mar 25, 2005
K050190 · APOLLO
- X-Ray Technologies, Inc.Nov 12, 1996
K963905 · RADIOGRAPHIC ITT TABLE
- Wuestec Medical, Inc.Jul 24, 1996
K955414 · XRT 400
- Septa Corp.May 4, 1995
K951146 · IMAGING TABLE
- Medtec, Inc.Apr 6, 1995
K950068 · CARBON FIBER COUCH INSERT
- Medical X-Ray Intl., Inc.Mar 31, 1995
K950442 · INFRARED EXPOSURE HAND SWITCH
- Philips Medical Systems North America, Inc.Mar 16, 1994
K940696 · SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
- Continental X-Ray Corp.Jun 14, 1993
K931724 · ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES