Devices

Name Classification Manufacturer Risk Class Country Source
Digital Linear Accelerators of type Primus, ONCOR and ARTISTE running Control Console software version 12.0.25 or 13.0.65 and syngo RT Therapist running software version 4.2.110 or 4.3.SP1 Siemens Healthcare Pty Ltd Australia
Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
e.cam and Symbia E systems (Nuclear medicine gamma camera system) Siemens Healthcare Pty Ltd Australia
Prostate-specific antigen (PSA) Assay performed on ADVIA Centaur, Centaur XP, Centaur XPT, and Centaur CP Analysers. An in vitro diagnostic medical device (IVD).PSA Assay (100 Tests) Siemens Healthcare Pty Ltd Australia
AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system) Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes). An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
SOMATOM Definition AS, Definition Edge and Definition Flash CT scanners with coupled contrast agent injectors in software version VA48A-SP2 (diagnostic computed tomography x-ray system) Siemens Healthcare Pty Ltd Australia
Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system) Siemens Healthcare Pty Ltd Australia
Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD). Clinical Chemistry and Clinical Toxicology Devices Siemens Healthcare Pty Ltd Australia
ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry Theophylline_2 Reagent Siemens Healthcare Pty Ltd Australia
Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ADVIA Centaur XPT System Siemens Healthcare Pty Ltd Australia
Hettich Centrifuge Bucket Model 4464-R. An in vitro diagnostic medical device (IVD)(used on StreamLAB Centrifuges, Aptio Centrifuges, FlexLab High Throughput Centrifuges and FlexLab) Siemens Healthcare Pty Ltd Australia
Dimension Vista Enzyme 2 Calibrator (used on the Dimension Vista System). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD) Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP Siemens Healthcare Pty Ltd Australia
ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems) Siemens Healthcare Pty Ltd Australia