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Manufacturers
Elekta Pty Ltd
제조사 모회사 (2017)
Elekta AB
Source
DHTGA
54 Events
Leksell GammaPlan 11.1 의 리콜
HexaPOD evo RT System with HexaPOD evo Module 의 리콜
Digital Accelerators with iViewGT or XVI 의 리콜
Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license option 의 리콜
ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning 의 리콜
MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record) 의 리콜
MOSAIQ Medical Oncology with software version 2.50.05 and higher 의 리콜
iGUIDE software 2.2(sites using iGUIDE 2.2.0 and 2.2.1) 의 리콜
Monaco (with the use of Elekta Motorised Wedges) 의 리콜
Monaco V 5.00 and higher (Radiation therapy treatment planning system software) 의 리콜
Monaco V 5.11 and V 5.20 (used for radiation treatment planning) 의 리콜
Monaco V5.10 and V5.20 (used for radiation treatment planning) 의 리콜
iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment) 의 리콜
Monaco with software versions 3.1 and higher (Radiation therapy treatment planning system) 의 리콜
MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery) 의 리콜
MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery) 의 리콜
Monaco software versions 5.10.00 and higher 의 리콜
Hexapod iGUIDE 2.1, iGUIDE 2.2 의 리콜
Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures) 의 리콜
MOSAIQ version 2.5 and above - Medical Oncology only 의 리콜
MONACO, version 5.10.00 and above (Radiation therapy treatment planning system) 의 리콜
Monaco 5.10.00(Radiation therapy treatment planning system) 의 리콜
MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatment planning and delivery)Sites affected will be those meeting ALL three criteria below:1) Running MOSAIQ Release 2.41 and higher 2) With at least one linac equipped with an Agility 160 multi-leaf collimator (MLC) head (Versa HD, Infinity, Axesse (EOS) or Synergy) 3) Who are treating with Stereotactic Cones 의 리콜
Focal Release 4.80.00 의 리콜
Monaco (radiation therapy planning system)Release 3.30 and above 의 리콜
Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (Electronic Imaging Device (EID) used with radiation therapy treatment) 의 리콜
Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures) 의 리콜
Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.) 의 리콜
Monaco and Focal (radiation treatment planning systems) 의 리콜
HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment) 의 리콜
MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery) 의 리콜
HexaPOD evo RT Couchtop (X-ray powered radiation therapy table) 의 리콜
XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system) 의 리콜
Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator system) 의 리콜
Integrity R1.1, R3.0 and R3.1(digital linear accelerator) 의 리콜
Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment) 의 리콜
Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator) 의 리콜
X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (Electronic Imaging Device (EID) used with radiation therapy treatment) 의 리콜
XiO versions 4.50 and higher (Radiation therapy treatment planning system) 의 리콜
Monaco RTP System (Radiation Treatment Planning System Software) 의 리콜
All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads 의 리콜
Monaco RTP System (Radiation Treatment Planning System Software)All releases of Monaco 의 리콜
Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment) 의 리콜
Elekta Integrity R3.0 Digital Linear Accelerator 의 리콜
Elekta Integrity Digital Linear Accelerator, version 1.1 의 리콜
Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use) 의 리콜
Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System) 의 리콜
Apex (Multileaf collimator used with Elekta linear accelerators) 의 리콜
XVI R3.5, R4.0, R4.2 and R4.5 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy) 의 리콜
XVI R3.5.1, R4.2.1 and R4.5.1 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy) 의 리콜
MOSAIQ (Radiation Oncology Information System). 의 리콜
Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)Machine Range: 105345 to 151675 (inclusive) 의 리콜
Agility (An integral beam limiting device used with linear accelerators) 의 리콜
Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 through 4.70.00 (Radiation Therapy Treatment Planning System)Elekta Monaco rel. 3.10.00 through 3.20.00 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 54 건
Leksell GammaPlan 11.1
모델명 / 제조번호(시리얼번호)
Leksell GammaPlan 11.1ARTG Number: 158043(Elekta Pty Ltd - Radionuclide system, therapeutic, stereotactic radiosurgery, application program software)
HexaPOD evo RT System with HexaPOD evo Module
모델명 / 제조번호(시리얼번호)
HexaPOD evo RT System with HexaPOD evo ModuleARTG Number:187340(Elekta Pty Ltd - Table, radiation therapy, x-ray, powered)
의료기기 분류등급
Radiology Devices
Digital Accelerators with iViewGT or XVI
모델명 / 제조번호(시리얼번호)
Digital Accelerators with iViewGT or XVI ARTG number: 111760
의료기기 분류등급
Radiology Devices
Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license option
모델명 / 제조번호(시리얼번호)
Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license optionARTG Number: 191025
ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning
모델명 / 제조번호(시리얼번호)
ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planningARTG Number: 187299
의료기기 분류등급
Radiology Devices
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