Devices

Name Classification Manufacturer Risk Class Country Source
N Latex ß2–Microglobulin Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ADVIA Centaur XPT. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Enzygnost Anti-VZV/IgG(For in vitro diagnostic use in testing to provide information about infection with or exposure to the Varicella zoster virus (VZV) Siemens Healthcare Pty Ltd Australia
Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMP Siemens Healthcare Pty Ltd Australia
AXIOM Artis FA, FC, dFA, dFC, dFCM, BA, BC, dBA, dBC, dBCM, MP, dMP systems with SW version VB23N/P Siemens Healthcare Pty Ltd Australia
AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35D Siemens Healthcare Pty Ltd Australia
RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 tests Siemens Healthcare Pty Ltd Australia
EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems) Siemens Healthcare Pty Ltd Australia
Dimension Vista 500/ Dimension Vista 1500 Intelligent Lab Systems, software versions V. 3.6.1 SP1 or V. 3.6.2. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Acuson 2000 ultrasound system (with structural foam core). Siemens Healthcare Pty Ltd Australia
Acuson SC200 ultrasound systems Siemens Healthcare Pty Ltd Australia
Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD) Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL Cholesterol Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry Systems (using Trinder and Trinder-like assays). An in vitro diagnostic medical device (IVD) Assays affected: Cholesterol_2, Cholesterol_c, Enzymatic Creatinine_2, Glucose Oxidase, Triglycerides_2, Triglycerides_2 concentrated, Uric Acid, Uric Acid concentrated reagents, Fructosamine.LDL Cholesterol Direct, Direct HDL Cholesterol, Glucose Oxidase, Concentrated reagents. Siemens Healthcare Pty Ltd Australia
syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
Cios Alpha mobile C-arm x-ray system Siemens Healthcare Pty Ltd Australia
ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs Siemens Healthcare Pty Ltd Australia
ACUSON SC2000 ultrasound systems with software versions VB10B and lower Siemens Healthcare Pty Ltd Australia
ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD) Siemens Healthcare Pty Ltd Australia
ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo Option Siemens Healthcare Pty Ltd Australia
RAPIDPoint 500 Blood Gas Analyzer Clinical Chemistry and Clinical Toxicology Devices Siemens Healthcare Pty Ltd Australia
N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)(Quality control reagent) Siemens Healthcare Pty Ltd Australia
Dimension Creatinine and Dimension Vista Creatinine Assays Siemens Healthcare Pty Ltd Australia
Artis systems used in conjunction with Artis table Siemens Healthcare Pty Ltd Australia