System, Simulation, Radiation Therapy
Radiology · 21 CFR 892.5840
Recent MDR events
142 adverse event reports on file
- DRUG/BIOLOGIC RADIATION THERAPYMar 10, 2020InjuryUnknownMW5093669
- SIMVIEW NTSep 23, 2019MalfunctionSiemens Healthcare Gmbh3002466018-2019-96544
- RADIATIONNov 13, 2014InjuryMW5039150
- RADIATIONNov 13, 2014InjuryMW5039151
- ACUITYMar 19, 2014InjuryVarian Medical Systems8020711-2014-00002
- SIMVIEW NT WITH IDISep 25, 2013MalfunctionSiemens Medical Solutions Usa, Inc., Radiation Oncology2910081-2013-07739
- XKNIFE 5.0 INSTALL KITNov 16, 2012MalfunctionIntegra Burlington, Ma, Inc.1222895-2012-00044
- XKNIFE 5.0 INSTALL KITNov 16, 2012MalfunctionIntegra Burlington, Ma, Inc.1222895-2012-00045
- XKNIFE 5.0 INSTALL KITNov 16, 2012MalfunctionIntegra Burlington, Ma, Inc.1222895-2012-00047
- XKNIFE 5.0 INSTALL KITNov 16, 2012MalfunctionIntegra Burlington, Ma, Inc.1222895-2012-00048
Event type breakdown
Recalls
13 recall events for this product code
- Siemens Medical Solutions USA, IncTerminatedNov 20, 2014
Siemens SimView NT and SimView NT with IDI simulation system components:
Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.
Z-0235-2015 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJan 17, 2014
SIMVIEW NT and SIMVIEW NT with IDI:
In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.
Z-0786-2014 · View FDA record ↗ - GE Healthcare, LLCTerminatedJan 30, 2013
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
Z-0754-2013 · View FDA record ↗ - GE Medical Systems, LLCTerminatedAug 17, 2009
AdvantageSim MD versions 7.4 through 7.6, Model 5160092.
It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
Z-1718-2009 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJan 13, 2009
Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.
Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.
Z-0646-2009 · View FDA record ↗ - Varian Medical Systems Oncology SystemsTerminatedJul 30, 2008
Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.
Z-1460-2008 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJun 28, 2008
Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems;
The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
Z-2196-2008 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJan 31, 2008
Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical
Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
Z-0281-2008 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJan 31, 2008
Si emans Simiae NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No. 54 96 992 ;Siemens Medical Solutions USA, Concord, CA 94520
Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
Z-0282-2008 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJan 31, 2008
Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Siemens Medical Solutions USA, Concord, CA 94520
Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
Z-0283-2008 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
510(k) clearances
70 clearances for this product code
- Ge Hungary KftMar 14, 2014
K132944 · ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
- Ge Hungary KftSep 4, 2013
K132045 · ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
- Acceletronics Digital Imaging, LLCAug 17, 2010
K101038 · RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
- Nucletron CorporationJun 15, 2009
K090706 · ONCENTRA SIMULATION 2.3
- Ikoetech, LLCDec 29, 2008
K083591 · IKOENGELO, VERSION 2
- Nucletron Corp.Sep 14, 2007
K072445 · INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
- Ikoetech, LLCJun 5, 2006
K061006 · IKOENGELO
- Nucletron CorporationOct 24, 2005
K052361 · SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM