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Manufacturers
Siemens Healthcare Pty Ltd
Manufacturer Parent Company (2017)
Siemens AG
Source
DHTGA
171 Events
Recall of ARTIS Q, ARTIS pheno systems and X-ray generator
Recall of Biograph, Symbia T and Symbia Intevo SPECT/CT systems
Recall of N Latex CDT. An in vitro diagnostic medical device (IVD)
Recall of ARTIS pheno systems
Recall of ARTIS pheno systems
Recall of ARTIS zee/Q systems with Large Display
Recall of SOMATOM go.Up and SOMATOM go.Now
Recall of Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic medical device (IVD).
Recall of ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Medical Device (IVD)
Recall of ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
Recall of Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD)
Recall of ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cable
Recall of Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40A
Recall of Biograph Horizon with VJ20A Software
Recall of ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licenses
Recall of Biograph mMR with software version syngo E11P
Recall of Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
Recall of syngo Workflow MLR
Recall of Artis One in conjunction with table
Recall of ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra
Recall of ADVIA Centaur Cyclosporine, DHEA-SO4, Folate and HBc IgM Assays An in vitro diagnostic medical device ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP
Recall of IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical device (IVD)
Recall of Artis systems with Artis tables
Recall of Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. An in vitro diagnostic medical device (IVD)
Recall of SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force
Recall of Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Thyroid Stimulating Hormone (TSHL) LOCI Free Thyroxine (FT4L) Thyroid Stimulating Hormone (TSH) Cardiac Troponin I (CTNI) Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)
Recall of SOMATOM go.Up and SOMATOM go. Now
Recall of Artis systems with wireless footswitch Products Affected: AXIOM Artis FC, AXIOM Artis MP, AXIOM Artis dTA, AXIOM Artis dFC, AXIOM Artis dTC, AXIOM Artis dBA, AXIOM Artis dMP, AXIOM Artis dFC Magnetic Navigation, AXIOM Artis dBC, Artis zee floor, Artis zee ceiling, Artis zee multi-purpose, Artis zee biplane, Artis zeego, Artis Q floor, Artis Q ceiling, Artis Q biplane, Artis zeego.Q, Artis Q.zen floor, Artis Q.zen biplane, Artis one, ARTIS pheno
Recall of Artis zee and Artis Q systems with software version VD11C
Recall of Artis one system with DP Transceiver below version 03
Recall of Artis zee biplane and Artis Q biplane systems
Recall of Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)
Recall of syngo Workflow MLR using Portal Radiologist
Recall of Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD)
Recall of ADVIA Chemistry Products - Ammonia, Salicylate and Alanine Aminotransferase Assays. An in vitro diagnostic medical device (IVD)
Recall of Artis Systems in conjunction with Artis Table
Recall of Sysmex CA-600 series with built-in barcode reader. An in vitro diagnostic medical device (IVD)
Recall of Nordic Neuro Lab Headphones used with Siemens MRI systems
Recall of Calibrator 30 (2 pack) used with ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, Centaur XP and Centaur XPT systems. An in vitro diagnostic medical device (IVD).
Recall of PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)
Recall of N Protein Standard SL and N/T Protein Controls SL when used with N Antiserum to Human Ceruloplasmin. An in vitro diagnostic medical device (IVD)
Recall of V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD)
Recall of Sensis system
Recall of RAPIDPoint 500 Blood Gas Analyser with V2.4 Software
Recall of ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device (IVD)
Recall of SOMATOM Force with software version VA50A
Recall of ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducer
Recall of 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).
Recall of N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).
Recall of ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
Recall of ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
Recall of AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)
Recall of Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD).
Recall of Wireless Foot Switch - Artis systems
Recall of Artis Q Systems with A100G generators
Recall of Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302
Recall of ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).
Recall of Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital x-ray system)
Recall of ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).
Recall of Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD).
Recall of ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094
Recall of Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).
Recall of 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).
Recall of Mammomat Inspiration System with software version VB30 and Biopsy functionality
Recall of ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dimension Vista LOCI Progesterone; Assay: Immulite/Immulite 1000 Progesterone; Assay: Immulite 2000 Progesterone
Recall of Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).
Recall of Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnostic medical device (IVD).
Recall of Biograph mCT and Biograph mCT Flow
Recall of Artis zee, Artis Q and Artis Q.zen systems with software version VD11B
Recall of CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnostic medical device (IVD).
Recall of Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic medical device (IVD).
Recall of Artis zee with sw versions VC21C, VD11 and Megalix Cat+ X-Ray tubes
Recall of Artis Q systems with s/w version VD11 and Gigalix X-Ray tubes
Recall of AXIOM Artis systems with s/w version VB35E and Megalix X-Ray tubes
Recall of SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
Recall of SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
Recall of SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
Recall of Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD).
Recall of MAGNETOM Combi Dockable Neurosurgery Table
Recall of Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)
Recall of Aptio Automation Modules. An in vitro diagnostic medical device (IVD).
Recall of Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical device (IVD)
Recall of Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro diagnostic medical device (IVD)
Recall of RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).
Recall of Iron Assay performed with the Dimension & Dimension Vista Systems. An in vitro diagnostic medical device (IVD)
Recall of IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovirus (CMV)). An in vitro diagnostic medical device (IVD)
Recall of Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).
Recall of ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device (IVD)
Recall of RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).
Recall of syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQ
Recall of syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a component of one or more radiation therapy systems)
Recall of 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
Recall of Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD)
Recall of ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)
Recall of e.cam and Symbia E systems (Nuclear medicine gamma camera system)
Recall of 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)
Recall of AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)
Recall of 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).
Recall of 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)
Recall of Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system)
Recall of Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).
Recall of ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)
Recall of ADVIA Chemistry Theophylline_2 Reagent
Recall of Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)
Recall of Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An in vitro diagnostic medical device (IVD)
Recall of Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)
Recall of ADVIA Centaur XPT System
Recall of 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)
Recall of Dimension Vista Enzyme 2 Calibrator (used on the Dimension Vista System). An in vitro diagnostic medical device (IVD)
Recall of Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)
Recall of 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
Recall of ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)
Recall of ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. An in vitro diagnostic medical device (IVD)
Recall of Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). An in vitro diagnostic medical device (IVD)
Recall of RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)
Recall of e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)
Recall of Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)
Recall of Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System. An in vitro diagnostic medical device (IVD)
Recall of Symbia E and e.cam collimator (nuclear imaging gamma camera system)
Recall of Versant kPCR Molecular System Sample Preparation
Recall of e.cam system (Nuclear medicine gamma camera system )
Recall of Cios Alpha (Portable fluoroscopic x-ray system)
Recall of Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging system)
Recall of Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
Recall of AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)
Recall of Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)
Recall of ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD)
Recall of Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)
Recall of ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays
Recall of BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)
Recall of INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)
Recall of ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD)
Recall of 96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)
Recall of All Magnetom MRI systems with superconductive magnets
Recall of ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3
Recall of syngo X-Workplace with software VD10E and tabcard ”4D”Siemens
Recall of ADVIA Chemistry Halogen Lamp
Recall of ADVIA Centaur and ADVIA Centaur XP
Recall of Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System (RMS) Dimension RxL Max HM
Recall of Artis systems with large display module
Recall of SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"
Recall of N Latex ß2–Microglobulin
Recall of ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)
Recall of ADVIA Centaur XPT. An in vitro diagnostic medical device (IVD)
Recall of 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)
Recall of Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMP
Recall of AXIOM Artis FA, FC, dFA, dFC, dFCM, BA, BC, dBA, dBC, dBCM, MP, dMP systems with SW version VB23N/P
Recall of AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35D
Recall of 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
Recall of EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD)
Recall of Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems)
Recall of 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)
Recall of Acuson 2000 ultrasound system (with structural foam core).
Recall of Acuson SC200 ultrasound systems
Recall of 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
Recall of 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.
Recall of syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD)
Recall of Cios Alpha mobile C-arm x-ray system
Recall of ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs
Recall of ACUSON SC2000 ultrasound systems with software versions VB10B and lower
Recall of ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD)
Recall of ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo Option
Recall of RAPIDPoint 500 Blood Gas Analyzer
Recall of N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)(Quality control reagent)
Recall of Dimension Creatinine and Dimension Vista Creatinine Assays
Recall of Artis systems used in conjunction with Artis table
Recall of Siemens e.cam Systems (Nuclear medicine gamma camera)
Recall of Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E
Recall of Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
Recall of ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines
Recall of ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31A
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170 devices in the database
ARTIS Q, ARTIS pheno systems and X-ray generator
Model / Serial
ARTIS Q, ARTIS pheno systems and X-ray generatorCatalogue number: 10848282, 10848281, 10848280, 10848283, 10848355, 10849000ARTG Number: 273952(Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
Biograph, Symbia T and Symbia Intevo SPECT/CT systems
Model / Serial
Biograph, Symbia T and Symbia Intevo SPECT/CT systemsCatalogue Numbers: 8728581, 10097303, 10097289, 10097302, 10532746, 10532748, 10528958, 10529158, 10529160, 10529161, 10528955, 10507786, 10507786, 10534160, 10248669, 10248672, 10248673, 10248670, 10525581, 10764804, 10764802, 10764803, 11007962, 10764801, 10275007, 10275010, 10275008, 10275009 and 8717733.ARTG Numbers: 123883, 144218 and 271560.
N Latex CDT. An in vitro diagnostic medical device (IVD)
Model / Serial
N Latex CDT. An in vitro diagnostic medical device (IVD)Catalogue Number: OPCS03Material Number: 10445996Lot Numbers: 47167, 47168, 47430, 47431, 47433, 47597, 47642, 47727, 47848, 48013, 48014, 48118 & 48169ARTG number: 178153(Siemens Healthcare - Clinical chemistry-specific protein IVDs)
ARTIS pheno systems
Model / Serial
ARTIS pheno systemsCatalogue Number: 10849000ARTG Number: 273952
ARTIS zee/Q systems with Large Display
Model / Serial
ARTIS zee/Q systems with Large DisplayCatalogue Numbers: 10094137, 10094135, 10280959, 10848281, 10848283, 10094141WAND Number: 160415-WAND-6LT3VYARTG Number: 273952Siemens Healthcare - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital
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Siemens Healthcare Pty Ltd
Manufacturer Parent Company (2017)
Siemens AG
Source
RLMPH
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