International Medical Devices Database

Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)

Modèle / numéro de série
Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)Multiple catalogue numbers affectedARTG Number: 123883
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de Symbia T Series and Symbia Intevo Camera System (SPECT/CT diagnostic imaging system)

Monaco and Focal (radiation treatment planning systems)

Modèle / numéro de série
Monaco and Focal (radiation treatment planning systems)Monaco: versions 3.20.00 and higher Focal: versions 4.70 & 4.80 ARTG numbers: 215960 & 186853
Classification du dispositif
Radiology Devices
Manufacturer
Elekta Pty Ltd
1 Event
- Rappel de Monaco and Focal (radiation treatment planning systems)

V5Ms transesophageal transducer (used for ultrasound imaging)

Modèle / numéro de série
V5Ms transesophageal transducer (used for ultrasound imaging)Catalogue numbers: 08263703 and 8264577Serial number range: 32800000 to 42300000 (manufactured 2013-2014)ARTG number: 186302
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de V5Ms transesophageal transducer (used for ultrasound imaging)

4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery ...

Modèle / numéro de série
4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)Product code: H51Serial Numbers: H514278, H514544, H515102, H51B568, H513894, H515619 & H51B100ARTG Number: 116839
Classification du dispositif
Radiology Devices
Manufacturer
Varian Medical Systems Australasia Pty Ltd
1 Event
- Rappel de 4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)

IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)

Modèle / numéro de série
IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)All versions of IntelliSpace PACS 4.4 with Auto Export Feature Enabled are affectedARTG Number: 178437
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)

Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option ...

Modèle / numéro de série
Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1ARTG number: 98868
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1

MultiDiagnost Eleva with Flat Detector Systems(Fluoroscopic diagnostic digital x-ray system)

Modèle / numéro de série
MultiDiagnost Eleva with Flat Detector Systems(Fluoroscopic diagnostic digital x-ray system)Product codes: 708037 & 708038ARTG Number 98560
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de MultiDiagnost Eleva with Flat Detector Systems(Fluoroscopic diagnostic digital x-ray system)

Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)

Modèle / numéro de série
Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)Multiple Product Codes and Serial NumbersARTG Number: 175708
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Allura Xper Systems(Fluoroscopic angiographic digital x-ray system)

BrightView SPECT, BrightView X and BrightView XCT Software Software Versions: V1.2.3 (Brightview ...

Modèle / numéro de série
BrightView SPECT, BrightView X and BrightView XCT SoftwareSoftware Versions: V1.2.3 (Brightview SPECT and X) / V2.5.3 (Brightview XCT)ARTG number: 117440
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de BrightView SPECT, BrightView X and BrightView XCT Software Software Versions: V1.2.3 (Brightview SPECT and X) / V2.5.3 (Brightview XCT)

BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (...

Modèle / numéro de série
BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT) ARTG number: 117440
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de BrightView SPECT, BrightView X and BrightView XCT Systems Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT)

DX-D 600 X-ray System, Versions below 3.6

Modèle / numéro de série
DX-D 600 X-ray System, Versions below 3.6All full automatic & semi-automatic devices below version 3.6ARTG Number: 173861
Classification du dispositif
Radiology Devices
Manufacturer
AGFA HealthCare Australia
1 Event
- Rappel de DX-D 600 X-ray System, Versions below 3.6

Philips Ultrasound QLAB versions 10 and 10.1 .x with a2DQ and/or aCMQ plug-ins

Modèle / numéro de série
Philips Ultrasound QLAB versions 10 and 10.1 .x with a2DQ and/or aCMQ plug-insARTG Number: 100468
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Philips Ultrasound QLAB versions 10 and 10.1 .x with a2DQ and/or aCMQ plug-ins

EPIQ5 Vi .0.x/1 .1 .x with QLAB a2DQ and/or aCMQ plug-ins

Modèle / numéro de série
EPIQ5 Vi .0.x/1 .1 .x with QLAB a2DQ and/or aCMQ plug-insARTG Number: 100468
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de EPIQ5 Vi .0.x/1 .1 .x with QLAB a2DQ and/or aCMQ plug-ins

EPIQ 7 V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-ins

Modèle / numéro de série
EPIQ 7 V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-insARTG Number: 100468
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de EPIQ 7 V1.0.x/1.1.x with QLAB a2DQ and/or aCMQ plug-ins

Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps

Modèle / numéro de série
Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-AppsARTG Number: 100468
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Philips Ultrasound Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps

DRX Revolution Mobile X-Ray System

Modèle / numéro de série
DRX Revolution Mobile X-Ray SystemSerial numbers: 101 to 764ARTG number: 194055
Classification du dispositif
Radiology Devices
Manufacturer
Carestream Health Australia Pty Ltd
1 Event
- Rappel de DRX Revolution Mobile X-Ray System

iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localis...

Modèle / numéro de série
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)ARTG Number: 121114
Classification du dispositif
Radiology Devices
Manufacturer
Brainlab Australia Pty Ltd
1 Event
- Rappel de 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)

syngo.plaza(Radiology picture archiving/communication system)

Modèle / numéro de série
syngo.plaza(Radiology picture archiving/communication system)Lot numbers: 10863171 & 10863173ARTG number: 120332
Classification du dispositif
Radiology Devices
Manufacturer
Siemens Ltd
1 Event
- Rappel de syngo.plaza(Radiology picture archiving/communication system)

CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)

Modèle / numéro de série
CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)Serial numbers starting WEYA618-627, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD.Manufacturing Date: June 2012 to September 2014ARTG Number: 136114 and 136106
Classification du dispositif
Radiology Devices
Manufacturer
Carestream Health Australia Pty Ltd
1 Event
- Rappel de CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)

CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic R...

Modèle / numéro de série
CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)Part numbers: 9065 and 9067Units Affected: All batteries with date codes 2808 or earlierARTG Number: 98887
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)

GE Healthcare MRI systems with superconducting magnets

Modèle / numéro de série
GE Healthcare MRI systems with superconducting magnets ARTG Number: 223115
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de GE Healthcare MRI systems with superconducting magnets

Allura Systems: Field extensions Vascular R7.6

Modèle / numéro de série
Allura Systems: Field extensions Vascular R7.6Product Code: 722134Applies to: Actuator Long Assy: 989600-184-654ARTG number: 98560
Classification du dispositif
Radiology Devices
Manufacturer
Philips Electronics Australia Ltd
1 Event
- Rappel de Allura Systems: Field extensions Vascular R7.6

Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

Modèle / numéro de série
Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.ARTG number: 98099
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)

Modèle / numéro de série
EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)Product Version Number: ExacTrac 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0ARTG Number: 121226
Classification du dispositif
Radiology Devices
Manufacturer
Brainlab Australia Pty Ltd
1 Event
- Rappel de EXACTRAC 6.x (Image Guided RadiationTherapy Patient Positioning System)

Kenex ceiling-suspended radiation shields and surgical lamps

Modèle / numéro de série
Kenex ceiling-suspended radiation shields and surgical lampsARTG number: 136957
Classification du dispositif
Radiology Devices
Manufacturer
GE Healthcare Australia Pty Ltd
1 Event
- Rappel de Kenex ceiling-suspended radiation shields and surgical lamps

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