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  • Dispositivo 3547
  • Fabricante 3547
  • Evento 3558
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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
DRX Revolution Mobile X-Ray System Radiology Devices Carestream Health Australia Pty Ltd Australia DHTGA
iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1) Radiology Devices Brainlab Australia Pty Ltd Australia DHTGA
syngo.plaza(Radiology picture archiving/communication system) Radiology Devices Siemens Ltd Australia DHTGA
CS 8100 & CS 8100 3D (A diagnostic dental x-ray system) Radiology Devices Carestream Health Australia Pty Ltd Australia DHTGA
CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system) Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
GE Healthcare MRI systems with superconducting magnets Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
Allura Systems: Field extensions Vascular R7.6 Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354. Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System) Radiology Devices Brainlab Australia Pty Ltd Australia DHTGA
Kenex ceiling-suspended radiation shields and surgical lamps Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
ONCENTRA Brachy version 3.x and 4.x Radiology Devices Nucletron Pty Limited Australia DHTGA
SOMATOM Emotion 6 / 16 Slice Configuration systems manufactured before February 2008 Radiology Devices Siemens Ltd Australia DHTGA
Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option Radiology Devices Siemens Ltd Australia DHTGA
Multiple Allura systems(Fluoroscopic x-ray systems) Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
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 Radiology Devices Elekta Pty Ltd Australia DHTGA
iPlan RT Dose, versions 4.0 and 4.1 (including all subversions)(Radiation Treatment Planning Software) Radiology Devices Brainlab Australia Pty Ltd Australia DHTGA
Tumor Localization (TumorLOC) software application used on Philips PET/CT combination diagnostic imaging systems PET/CT system with TumorLOC supplied in Australia: GEMINI TF 64 Slice Radiology Devices Philips Electronics Australia Ltd Australia DHTGA
Siemens e.cam Systems (Nuclear medicine gamma camera) Radiology Devices Siemens Healthcare Pty Ltd Australia DHTGA
MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System Affected Systems: Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
EXACTRAC Version 6.0.0 through to 6.0.5 (Image Guided Radiation Therapy Patient Positioning System) Radiology Devices Brainlab Australia Pty Ltd Australia DHTGA
Monaco 5.10.00(Radiation therapy treatment planning system) Radiology Devices Elekta Pty Ltd Australia DHTGA
GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T Radiology Devices GE Healthcare Australia Pty Ltd Australia DHTGA
ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions10.X, 11.X, 13.0 or 13.5 with Clinical Assessment licence only Radiology Devices Varian Medical Systems Australasia Pty Ltd Australia DHTGA
Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher and Centricity Universal Viewer versions 6.0 and higher (used for storage and retrieval of images used in radiology) Radiology Devices GE Healthcare IITS Australia Pty Ltd Australia DHTGA
MONACO, version 5.10.00 and above (Radiation therapy treatment planning system) Radiology Devices Elekta Pty Ltd Australia DHTGA
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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