Tube Mount, X-ray, Diagnostic
Radiology · 21 CFR 892.1770
Recent MDR events
85 adverse event reports on file
- Tube mount, x-ray, diagnosticFeb 26, 2026MalfunctionShinyoung For M Co., Ltd.3005920099-2006-00001
- DEL MEDICAL/UNIVERSALJan 2, 2026MalfunctionDel Medical, Inc.23943089
- SEDECALJun 25, 2018MalfunctionSedecal Sa9617251-2018-00001
- DCTMOct 19, 2015MalfunctionDel Medical Imaging Corporation1418964-2015-00002
- TUBESTANDOct 9, 2013UnkMW5032245
- HALOAug 27, 2012MalfunctionCore Labs, LlcMW5026699
- SUINSA (MARKETED BY CARESTREAM)Apr 20, 2010MalfunctionSuinsa1000404222-2009-00002
- EPICARE COLUMNOct 8, 2009MalfunctionHill-rom Architecural Products / Hill-rom Co. Inc1836145-2009-00003
- SUINSA (MARKETED BY CARESTREAM)Sep 28, 2009MalfunctionSuinsa1000404222-2009-00001
- PRIMA XTEND ARMSep 25, 2009MalfunctionHill-rom Architectural Products - Hill-rom Co. Inc1836145-2009-00002
Event type breakdown
Recalls
13 recall events for this product code
- SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONOpen, ClassifiedNov 13, 2025
Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M
Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.
Z-0499-2026 · View FDA record ↗ - SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONOpen, ClassifiedJul 31, 2023
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units
Eight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.
Z-2270-2023 · View FDA record ↗ - Summit Industries Inc.TerminatedDec 1, 2014
The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube housing assembly for a medical radiographic procedure. Th
The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.
Z-0468-2015 · View FDA record ↗ - Del Medical Systems GroupTerminatedJun 30, 2009
Ceiling Tube Mount Ceiling Tube Mount (CTM)/Digital Ceiling Tube Mount (DCTM) with 5 inch or 10 inch Column Extensions; a radiographic x-ray tube suspension sys
There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator.
Z-1247-2009 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJul 6, 2006
3D-I/III Ceiling Stand. Diagnostic x-ray tube mount
Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.
Z-1205-06 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedDec 31, 2005
3D TOP Ceiling Stand. X-Ray System model number 8773673
screws on the rollers may become loose
Z-0335-06 · View FDA record ↗ - Del Medical Systems GroupTerminatedMay 11, 2005
Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131
The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator.
Z-0816-05 · View FDA record ↗ - Fischer Imaging CorporationTerminatedMay 3, 2005
VersaRad Generator
Some VersaRad Systems have a faulty weld that may result in oil leakage.
Z-0787-05 · View FDA record ↗ - Del Medical Systems GroupTerminatedJul 20, 2004
DCTM Digital Ceiling Tube Mount, model DCTM; a fully counter-balanced radiographic x-ray tube suspension system designed to facilitate a wide range of procedure
There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units.
Z-0712-04 · View FDA record ↗ - Fischer Imaging CorporationTerminatedJul 20, 2004
VersaRad/Traumex General Radiographic System.
If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury.
Z-0974-04 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Drgem Corporation
Gwangmyeong-si Gyeongbuk, KR
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Upper Cervical Store, Inc.
Calgary Alberta, CA
Shimane Shimadzu Corporation
IZUMO Shimane, JP
Cis Computerised Imaging Services Pty Ltd
Bondi Junction New South Wales, AU
Dk Medical Systems Co., Ltd.
Pyeongtaek-si Gyeonggi, KR
Compania Mexicana De Radiologia Cgr, S.a. De C.v.
QUERETARO, MX
Shinyoung For M Co., Ltd.
Namyangju-si Gyeonggi, KR
Accogent Pausch
Tinton Falls, NJ, US
Siemens Healthineers Ag
KEMNATH Bavaria, DE
Arcoma Ab
VAXJO Kronoberg, SE
Summit Industries, Llc
Niles, IL, US
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Pausch Medical Gmbh
ERLANGEN Bavaria, DE
Zogear Medical Co., Ltd.
Yizheng Jiangsu, CN
Livermoretech,inc
Plano, TX, US
Drgem Corporation (gimcheon Factory)
Gimcheon-si Gyeongbuk, KR
Ge Medical Systems Monterrey Mexico, S.a. De C.v.
APODACA Nuevo Leon, MX
Dexcowin Co., Ltd.
Seoul, KR
Aspen Imaging Healthcare, Inc
Plano, TX, US
Sedecal S.a.
ALGETE Madrid (Province), ES
Air Techniques, Inc.
Melville, NY, US
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
510(k) clearances
40 clearances for this product code
- Wuestec Medical, Inc.Mar 27, 1996
K935123 · SUPERSTAND 300
- Scott Imaging Intl., Inc.Feb 15, 1995
K946261 · MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
- Acoma Medical Imaging, Inc.Jul 29, 1994
K941004 · CTS SYSTEM
- Acoma Medical Imaging, Inc.Jul 29, 1994
K941017 · F/C/W TUBESTAND
- Xri, Inc.Jun 9, 1994
K940442 · MPR-814
- Dpa Consulting, Inc.Dec 13, 1993
K935004 · MODEL ALPHA TS-2
- Wuestec Medical, Inc.Aug 16, 1993
K933253 · SUPERSTAND 3000
- Bennett X-Ray Corp.Dec 17, 1992
K925716 · BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC