International Medical Devices Database

XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)

Modèle / numéro de série
XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)

syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and co...

Modèle / numéro de série
syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)ARTG Number: 120332
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)

Pinnacle3 Radiation Treatment Planning System, software version 9.0

Modèle / numéro de série
Pinnacle3 Radiation Treatment Planning System, software version 9.0ARTG Number: 118156
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Pinnacle3 Radiation Treatment Planning System, software version 9.0

On-Board Imager (OBI) (used with linear accelerators for verification of correct patient position...

Modèle / numéro de série
On-Board Imager (OBI) (used with linear accelerators for verification of correct patient position in relation to isocenter and verification of treatment fields)ARTG Number: 117950
Classification du dispositif
Radiology Devices
Manufacturer
Varian Medical Systems Australasia Pty Ltd
1 Event
- Rappel de On-Board Imager (OBI) (used with linear accelerators for verification of correct patient position in relation to isocenter and verification of treatment fields)

Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discov...

Modèle / numéro de série
Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems) Multiple System IDsARTG Number: 108415
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products (Full body magnetic resonance imaging systems)

ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

Modèle / numéro de série
ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus SystemsARTG Number: 117642
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems

Kenex suspension arm with radiation shield and/or surgical lamp

Modèle / numéro de série
Kenex suspension arm with radiation shield and/or surgical lampARTG Number: 136957
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Kenex suspension arm with radiation shield and/or surgical lamp

ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)

Modèle / numéro de série
ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)Product Version Number: ExacTrac 5.5.5ARTG Number: 121226
Classification du dispositif
Radiology Devices
Manufacturer
Brainlab Australia Pty Ltd
1 Event
- Rappel de ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)

Modèle / numéro de série
550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)Lot Number: 7346534ARTG Number: 165502
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de 550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)

Luminos dRF (Fluoroscopic diagnostic x-ray systems)

Modèle / numéro de série
Luminos dRF (Fluoroscopic diagnostic x-ray systems)Catalogue number: 10094200 ARTG Number: 102182
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de Luminos dRF (Fluoroscopic diagnostic x-ray systems)

SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body com...

Modèle / numéro de série
SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray system)Catalogue numbers: 10045692, 10165566, 10165888, 10165977, 10415118, 10415119, 10415116 & 10415117ARTG number: 142119
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM Spirit/Spirit Power Systems (Full-body computed tomography (CT) diagnostic x-ray system)

MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)

Modèle / numéro de série
MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)ARTG Number: 178437
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)

Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Dis...

Modèle / numéro de série
Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)ARTG Number: 108415
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)

HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)

Modèle / numéro de série
HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)ARTG Number: 187340
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de HexaPOD evo RT Couchtop (X-ray powered radiation therapy table)

Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

Modèle / numéro de série
Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity FlexARTG Number: 98868
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system)

Modèle / numéro de série
RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system)ARTG Number: 195288
Classification du dispositif
Radiology Devices
Manufacturer
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
1 Event
- Rappel de RaySearch RayStation, version 4.0.3 (Radiation therapy treatment planning system)

MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflow...

Modèle / numéro de série
MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 206321
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)

Ingenia, Intera and Achieva MR Systems on software version R5.1.1 and R5.1.2

Modèle / numéro de série
Ingenia, Intera and Achieva MR Systems on software version R5.1.1 and R5.1.2ARTG Number: 98887
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Ingenia, Intera and Achieva MR Systems on software version R5.1.1 and R5.1.2

HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within...

Modèle / numéro de série
HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)ARTG Number: 187340
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de HexaPOD evo RT Systems running iGUIDE 2.0.0 - 2.0.2 (used for accurate patient positioning within a radiation therapy treatment environment)

ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B

Modèle / numéro de série
ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30BARTG Number: 137563
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de ACUSON S Family Ultrasound Systems with software versions VC25D, VC30A, VC30B

C-Series High Energy Linear Accelerator Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clina...

Modèle / numéro de série
C-Series High Energy Linear Accelerator Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac CX, Clinac 2100 c/D, Clinac 2300C/D, Clinac DX, Clinac 21 EX, Clinac 23 EXARTG Number: 116839
Classification du dispositif
Radiology Devices
Manufacturer
Varian Medical Systems Australasia Pty Ltd
1 Event
- Rappel de C-Series High Energy Linear Accelerator Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac CX, Clinac 2100 c/D, Clinac 2300C/D, Clinac DX, Clinac 21 EX, Clinac 23 EX

Brainlab Patient Data Manager

Modèle / numéro de série
Brainlab Patient Data ManagerProduct Version Number: 2.0Sub Versions: 2.0.0, 2.0.1 & 2.0.2ARTG Number: 96517
Classification du dispositif
Radiology Devices
Manufacturer
Brainlab Australia Pty Ltd
1 Event
- Rappel de Brainlab Patient Data Manager

Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

Modèle / numéro de série
Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.ARTG number: 98887
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Philips Ingenia 1.5T and 3.0T MR Systems Shipped between 2nd December 2013 and 7th March 2014.

Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)

Modèle / numéro de série
Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)Product codes: 722028, 722035ARTG number: 98560
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)

Kodak DirectView DR 7500 (Diagnostic x-ray system)

Modèle / numéro de série
Kodak DirectView DR 7500 (Diagnostic x-ray system)All batches Manufactured between 2005 and 2011ARTG Number: 136112
Classification du dispositif
Radiology Devices
Manufacturer
Carestream Health Australia Pty Ltd
1 Event
- Rappel de Kodak DirectView DR 7500 (Diagnostic x-ray system)

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