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  • Dispositivo 3547
  • Fabricante 3547
  • Evento 3558
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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Brilliance 64 and Ingenuity CT systems with software version 4.0.0.xx379 (Full body diagnostic CT X-ray system) Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
Clinac, Trilogy, Novalis Tx and Unique linear accelerators (Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumours and other conditions requiring radiation therapy) Radiology Devices Varian Medical Systems Australasia Pty Ltd Australia DHTGA
MOSAIQ (Radiation Oncology Information System). Radiology Devices Elekta Pty Ltd Australia DHTGA
ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management) Radiology Devices Varian Medical Systems Australasia Pty Ltd Australia DHTGA
ARIA Radiation Oncology System (information system), versions: 11.0 below 11.0.55, Build 11.02.28 and 11.0.34 Radiology Devices Varian Medical Systems Australasia Pty Ltd Australia DHTGA
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) Radiology Devices Elekta Pty Ltd Australia DHTGA
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) Radiology Devices Elekta Pty Ltd Australia DHTGA
Eclipse Treatment Planning System, (Radiation therapy treatment planning system), version 11Version 11 with PBC 11.0.21, 11.0.30 Radiology Devices Varian Medical Systems Australasia Pty Ltd Australia DHTGA
Medtronic Navigation O-Arm Imaging System (Digital fluoroscopic diagnostic portable x-ray system) Radiology Devices Medtronic Australasia Pty Ltd Australia DHTGA
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems) Radiology Devices Siemens Ltd Australia DHTGA
Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system) Software versions prior to 8.1.0.3 are affected Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System) Radiology Devices Elekta Pty Ltd Australia DHTGA
Vitrea Enterprise Suite : Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX (Tool for analysis of diagnostic images) Radiology Devices Toshiba Australia Pty Ltd Australia DHTGA
Vitrea Enterprise Suite: Vitrea, Vitrea fX and VitreaCore (Tool for analysis of diagnostic images) Radiology Devices CELEO Pty Ltd Australia DHTGA
Advantx, Innova 2000, Innova 2100 IQ, Innova 3100, Innova 3100 IQ, Innova 4100, Innova 4100 IQ Cardiovascular X-ray Imaging Systems equipped with Video monitor Suspension model numbers 2236709, 2353620, 2223039-2 and 2270677-2 Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
Artis Zeego systems (Angiographic fluoroscopic digital diagnostic x-ray system) with software Artis VC20x/VC21A/VD10x that have a DSA license installed Radiology Devices Siemens Ltd Australia DHTGA
IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use) Radiology Devices Elekta Pty Ltd Australia DHTGA
IMPAX 5.2 DB Server, version 5.2 (Picture archiving and communication system, PACS) Radiology Devices AGFA HealthCare Australia Australia DHTGA
BrightView SPECT (single photon emission computed tomography system) Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advantage Workstation 4.6, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 ) Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
Monaco RTP System (Radiation Treatment Planning System Software)All releases of Monaco Radiology Devices Elekta Pty Ltd Australia DHTGA
Infinia, VG, VG Hawkeye and Helix nuclear medical systemsAll Infinia nuclear medicine systems, manufactured from 2003-2013VG and VG Hawkeye nuclear medicine systems, manufactured from 1996-2003 Helix nuclear medicine systems, manufactured from 1992-1996 (by Elscint Ltd) Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads Radiology Devices Elekta Pty Ltd Australia DHTGA
GEHC Discovery NM/CT 670 Nuclear Medicine System Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
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