Devices

Name Classification Manufacturer Risk Class Country Source
V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Sensis system Siemens Healthcare Pty Ltd Australia
RAPIDPoint 500 Blood Gas Analyser with V2.4 Software Siemens Healthcare Pty Ltd Australia
ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
SOMATOM Force with software version VA50A Siemens Healthcare Pty Ltd Australia
ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducer Siemens Healthcare Pty Ltd Australia
Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Prolactin (PRL) & Thyroid Stimulating Hormone (TSH) assays. An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM) Siemens Healthcare Pty Ltd Australia
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
Wireless Foot Switch - Artis systems Siemens Healthcare Pty Ltd Australia
Artis Q Systems with A100G generators Siemens Healthcare Pty Ltd Australia
Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302 Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital x-ray system) Siemens Healthcare Pty Ltd Australia
ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094 Siemens Healthcare Pty Ltd Australia
Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
Calibrator A used with ADVIA Centaur FT4 (free thyroxine) assay on the ADVIA Centaur, Centaur XP, Centaur XPT Systems. An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia
Mammomat Inspiration System with software version VB30 and Biopsy functionality Siemens Healthcare Pty Ltd Australia
ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dimension Vista LOCI Progesterone; Assay: Immulite/Immulite 1000 Progesterone; Assay: Immulite 2000 Progesterone Clinical Chemistry and Clinical Toxicology Devices Siemens Healthcare Pty Ltd Australia
Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD). Siemens Healthcare Pty Ltd Australia