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Manufacturers
Elekta Pty Ltd
Manufacturer Parent Company (2017)
Elekta AB
Source
DHTGA
54 Events
Recall of Leksell GammaPlan 11.1
Recall of HexaPOD evo RT System with HexaPOD evo Module
Recall of Digital Accelerators with iViewGT or XVI
Recall of Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license option
Recall of ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planning
Recall of MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)
Recall of MOSAIQ Medical Oncology with software version 2.50.05 and higher
Recall of iGUIDE software 2.2(sites using iGUIDE 2.2.0 and 2.2.1)
Recall of Monaco (with the use of Elekta Motorised Wedges)
Recall of Monaco V 5.00 and higher (Radiation therapy treatment planning system software)
Recall of Monaco V 5.11 and V 5.20 (used for radiation treatment planning)
Recall of Monaco V5.10 and V5.20 (used for radiation treatment planning)
Recall of iGUIDE with software version 2.2.0 (used with HexPOD evo RT System, used for accurate patient positioning during radiation therapy treatment)
Recall of Monaco with software versions 3.1 and higher (Radiation therapy treatment planning system)
Recall of MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery)
Recall of MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery)
Recall of Monaco software versions 5.10.00 and higher
Recall of Hexapod iGUIDE 2.1, iGUIDE 2.2
Recall of Leksell Gammaknife Perfexion and Leksell Gammaknife Icon (used for stereotactic irradiation of head structures)
Recall of MOSAIQ version 2.5 and above - Medical Oncology only
Recall of MONACO, version 5.10.00 and above (Radiation therapy treatment planning system)
Recall of Monaco 5.10.00(Radiation therapy treatment planning system)
Recall of 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
Recall of Focal Release 4.80.00
Recall of Monaco (radiation therapy planning system)Release 3.30 and above
Recall of 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)
Recall of Leksell Gamma Knife Perfexion (teletherapy device indicated for stereotactic irradiation of head structures)
Recall of Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.)
Recall of Monaco and Focal (radiation treatment planning systems)
Recall of HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)
Recall of MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)
Recall of HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)
Recall of XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)
Recall of Desktop Pro R7.01 SP2 and Desktop Pro R4.2, R5.0, R5.1, R6.0, R6.1 (Linear accelerator system)
Recall of Integrity R1.1, R3.0 and R3.1(digital linear accelerator)
Recall of Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)
Recall of Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)
Recall of 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)
Recall of XiO versions 4.50 and higher (Radiation therapy treatment planning system)
Recall of Monaco RTP System (Radiation Treatment Planning System Software)
Recall of All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads
Recall of Monaco RTP System (Radiation Treatment Planning System Software)All releases of Monaco
Recall of Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)
Recall of Elekta Integrity R3.0 Digital Linear Accelerator
Recall of Elekta Integrity Digital Linear Accelerator, version 1.1
Recall of Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use)
Recall of Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)
Recall of Apex (Multileaf collimator used with Elekta linear accelerators)
Recall of 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)
Recall of 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)
Recall of MOSAIQ (Radiation Oncology Information System).
Recall of Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)Machine Range: 105345 to 151675 (inclusive)
Recall of Agility (An integral beam limiting device used with linear accelerators)
Recall of 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
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54 devices in the database
Leksell GammaPlan 11.1
Model / Serial
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
Model / Serial
HexaPOD evo RT System with HexaPOD evo ModuleARTG Number:187340(Elekta Pty Ltd - Table, radiation therapy, x-ray, powered)
Product Classification
Radiology Devices
Digital Accelerators with iViewGT or XVI
Model / Serial
Digital Accelerators with iViewGT or XVI ARTG number: 111760
Product Classification
Radiology Devices
Integrity R1.2 and Integrity R3.2 systems with a Precise Treatment Table for ATM license option
Model / Serial
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
Model / Serial
ERGO version 1.7.3 and higher and using a Multileaf Collimator (MLC) device for planningARTG Number: 187299
Product Classification
Radiology Devices
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