International Medical Devices Database

Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medic...

Modèle / numéro de série
Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing datesARTG Number: 200439
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670All manufacturing dates

Monaco RTP System (Radiation Treatment Planning System Software)

Modèle / numéro de série
Monaco RTP System (Radiation Treatment Planning System Software) Release 3.20.00 and 3.30.00 upgraded from 3.10.00 or 3.20.00 ARTG Number: 186856
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de Monaco RTP System (Radiation Treatment Planning System Software)

Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient posit...

Modèle / numéro de série
Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)Product Number: 43410Serial Number: 1223012002, 1223012007, 1223012008ARTG Number: 121226
Classification du dispositif
Radiology Devices
Manufacturer
Brainlab Australia Pty Ltd
1 Event
- Rappel de Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)

BrightView XCT(SPECT/CT diagnostic imaging system)

Modèle / numéro de série
BrightView XCT(SPECT/CT diagnostic imaging system)Model Numbers: 882482 and 882454ARTG Number: 117440
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de BrightView XCT(SPECT/CT diagnostic imaging system)

IntelliSpace PACS 4.4 (Picture archiving and communication system)

Modèle / numéro de série
IntelliSpace PACS 4.4 (Picture archiving and communication system)ARTG Number: 178437
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de IntelliSpace PACS 4.4 (Picture archiving and communication system)

Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system)

Modèle / numéro de série
Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system) Affected serial numbers: between VE94165 and VE95415ARTG Number: 146317
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3 (cardiovascular ultrasound system)

Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9...

Modèle / numéro de série
Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0. (Linear accelerator system)Product Codes: H14, H18, H27 and H29ARTG Number: 116839
Classification du dispositif
Radiology Devices
Manufacturer
Varian Medical Systems Australasia Pty Ltd
1 Event
- Rappel de Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0. (Linear accelerator system)

ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)

Modèle / numéro de série
ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)Serial numbers: A01100227 and 9807143ARTG Number: 117642
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de ADAC ARGUS Gamma Camera Systems (Nuclear medicine system)

Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)

Modèle / numéro de série
Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)Catalogue Number: 10094137Serial Numbers: 146367, 146674, 146718, 146880, 146910, 146926, 146967, 147054, 147092, 147095, 147101, 147102, 147518All systems equipped with a ceiling stand with serial numbers from 10701 to 11557ARTG Number: 120177
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)

PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

Modèle / numéro de série
PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44 ARTG Number: 156650
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)

Modèle / numéro de série
Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)ARTG Number: 191025
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)

Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with r...

Modèle / numéro de série
Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)ARTG Number: 214673
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)

Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Pres...

Modèle / numéro de série
Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray systems)All CRT monitors installed from January 1993ARTG Number: 99423
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII (diagnostic fluoroscopic x-ray systems)

Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management a...

Modèle / numéro de série
Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy SimulatorSoftware versions 11 and 13Product codes: H48, HIT and H77ARTG Numbers: 119983, 132638, 119995
Classification du dispositif
Radiology Devices
Manufacturer
Varian Medical Systems Australasia Pty Ltd
1 Event
- Rappel de Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy Simulator Software versions 11 and 13

Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems

Modèle / numéro de série
Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray SystemsModel Numbers: 5555000-5, 5555000-6 and 5421698ARTG Number: 201698
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Optima XR 220amx, Optima XR200amx with Digital Upgrade Mobile X-ray Systems

Integrity R1.1, R3.0 and R3.1(digital linear accelerator)

Modèle / numéro de série
Integrity R1.1, R3.0 and R3.1(digital linear accelerator)ARTG Number: 191025
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de Integrity R1.1, R3.0 and R3.1(digital linear accelerator)

PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity...

Modèle / numéro de série
PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system)ARTG Number: 156649
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system)

Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging Systems

Modèle / numéro de série
Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging SystemsSystem ID Numbers: 0910162006, 0910163011 and 0910064007ARTG Number: 93871
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging Systems

Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology pic...

Modèle / numéro de série
Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology picture archiving and communication system)ARTG Number: 158895
Classification du dispositif
Radiology Devices
Manufacturer
Device Technologies Australia Pty Ltd
1 Event
- Rappel de Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology picture archiving and communication system)

Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-r...

Modèle / numéro de série
Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-ray system)ARTG Number: 99423
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-ray system)

AXIOM Artis Systems (fluoroscopic angiographic x-ray system)

Modèle / numéro de série
AXIOM Artis Systems (fluoroscopic angiographic x-ray system)Catalogue Numbers: 7412807, 7728392Serial Numbers: 35031, 44018ARTG Number: 102173
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de AXIOM Artis Systems (fluoroscopic angiographic x-ray system)

Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All conf...

Modèle / numéro de série
Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurationsARTG Number: 200439
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye and VariCam Nuclear Medicine Systems, All configurations

RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning system)

Modèle / numéro de série
RayStation software versions 2.5, 3.0, 3.5, and 4.0 (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 RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning system)

RayStation 3.5 and 4.0 (Radiation therapy treatment planning system)

Modèle / numéro de série
RayStation 3.5 and 4.0 (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 RayStation 3.5 and 4.0 (Radiation therapy treatment planning system)

ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient posit...

Modèle / numéro de série
ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system)
Classification du dispositif
Radiology Devices
Manufacturer
Brainlab Australia Pty Ltd
1 Event
- Rappel de ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system)

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