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Crédits
Manufacturers
Siemens Healthcare Pty Ltd
Société-mère du fabricant (2017)
Siemens AG
Source
DHTGA
171 Events
Rappel de ARTIS Q, ARTIS pheno systems and X-ray generator
Rappel de Biograph, Symbia T and Symbia Intevo SPECT/CT systems
Rappel de N Latex CDT. An in vitro diagnostic medical device (IVD)
Rappel de ARTIS pheno systems
Rappel de ARTIS pheno systems
Rappel de ARTIS zee/Q systems with Large Display
Rappel de SOMATOM go.Up and SOMATOM go.Now
Rappel de Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic medical device (IVD).
Rappel de ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Medical Device (IVD)
Rappel de ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
Rappel de Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD)
Rappel de ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cable
Rappel de Siemens Somatom Emotion, Sensation, Perspective and Scope CT Systems with software versions VB42B, VC10A, VC20A, VC20B, VC28A, VC30A, VC30B and VC40A
Rappel de Biograph Horizon with VJ20A Software
Rappel de ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licenses
Rappel de Biograph mMR with software version syngo E11P
Rappel de Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
Rappel de syngo Workflow MLR
Rappel de Artis One in conjunction with table
Rappel de ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra
Rappel de 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
Rappel de IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical device (IVD)
Rappel de Artis systems with Artis tables
Rappel de 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)
Rappel de SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force
Rappel de 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)
Rappel de SOMATOM go.Up and SOMATOM go. Now
Rappel de 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
Rappel de Artis zee and Artis Q systems with software version VD11C
Rappel de Artis one system with DP Transceiver below version 03
Rappel de Artis zee biplane and Artis Q biplane systems
Rappel de Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)
Rappel de syngo Workflow MLR using Portal Radiologist
Rappel de Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Chemistry Products - Ammonia, Salicylate and Alanine Aminotransferase Assays. An in vitro diagnostic medical device (IVD)
Rappel de Artis Systems in conjunction with Artis Table
Rappel de Sysmex CA-600 series with built-in barcode reader. An in vitro diagnostic medical device (IVD)
Rappel de Nordic Neuro Lab Headphones used with Siemens MRI systems
Rappel de 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).
Rappel de PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)
Rappel de 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)
Rappel de V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD)
Rappel de Sensis system
Rappel de RAPIDPoint 500 Blood Gas Analyser with V2.4 Software
Rappel de ADVIA Centaur / XP / XPT / CP Systems Insulin (IRI) assay. An in vitro diagnostic medical device (IVD)
Rappel de SOMATOM Force with software version VA50A
Rappel de ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducer
Rappel de 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).
Rappel de N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).
Rappel de ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
Rappel de AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)
Rappel de Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD).
Rappel de Wireless Foot Switch - Artis systems
Rappel de Artis Q Systems with A100G generators
Rappel de Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302
Rappel de ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).
Rappel de Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital x-ray system)
Rappel de ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).
Rappel de Immulite 2000 / Immulite 2000 XPi Sex Hormone Binding Globulin (SHBG). An in vitro diagnostic medical device (IVD).
Rappel de ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094
Rappel de Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).
Rappel de 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).
Rappel de Mammomat Inspiration System with software version VB30 and Biopsy functionality
Rappel de ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dimension Vista LOCI Progesterone; Assay: Immulite/Immulite 1000 Progesterone; Assay: Immulite 2000 Progesterone
Rappel de Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).
Rappel de Dimension Vista V-LYTE Integrated Multisensor (used for measuring Na+/K+/Cl). An in vitro diagnostic medical device (IVD).
Rappel de Biograph mCT and Biograph mCT Flow
Rappel de Artis zee, Artis Q and Artis Q.zen systems with software version VD11B
Rappel de CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnostic medical device (IVD).
Rappel de Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic medical device (IVD).
Rappel de Artis zee with sw versions VC21C, VD11 and Megalix Cat+ X-Ray tubes
Rappel de Artis Q systems with s/w version VD11 and Gigalix X-Ray tubes
Rappel de AXIOM Artis systems with s/w version VB35E and Megalix X-Ray tubes
Rappel de SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
Rappel de SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
Rappel de SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
Rappel de Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD).
Rappel de MAGNETOM Combi Dockable Neurosurgery Table
Rappel de Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)
Rappel de Aptio Automation Modules. An in vitro diagnostic medical device (IVD).
Rappel de Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical device (IVD)
Rappel de Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro diagnostic medical device (IVD)
Rappel de RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).
Rappel de Iron Assay performed with the Dimension & Dimension Vista Systems. An in vitro diagnostic medical device (IVD)
Rappel de IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovirus (CMV)). An in vitro diagnostic medical device (IVD)
Rappel de Dimension & Dimension Vista Urine Opiates Screen assays. In vitro diagnostic medical devices (IVDs).
Rappel de ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device (IVD)
Rappel de RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).
Rappel de 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
Rappel de 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)
Rappel de 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
Rappel de Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Centaur Systems Calibrator U (Myoglobin). An in vitro diagnostic medical device (IVD)
Rappel de e.cam and Symbia E systems (Nuclear medicine gamma camera system)
Rappel de 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)
Rappel de AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)
Rappel de 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).
Rappel de 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)
Rappel de Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system)
Rappel de Stratus CS Acute Care Diagnostics System. An in vitro diagnostic medical device (IVD).
Rappel de ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)
Rappel de ADVIA Chemistry Theophylline_2 Reagent
Rappel de Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)
Rappel de Dimension Vista Creatinine (CRE2) Flex reagent cartridge (Used with Dimension Vista system). An in vitro diagnostic medical device (IVD)
Rappel de Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Centaur XPT System
Rappel de 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)
Rappel de Dimension Vista Enzyme 2 Calibrator (used on the Dimension Vista System). An in vitro diagnostic medical device (IVD)
Rappel de Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)
Rappel de 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
Rappel de ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. An in vitro diagnostic medical device (IVD)
Rappel de Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). An in vitro diagnostic medical device (IVD)
Rappel de RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)
Rappel de e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)
Rappel de Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)
Rappel de Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System. An in vitro diagnostic medical device (IVD)
Rappel de Symbia E and e.cam collimator (nuclear imaging gamma camera system)
Rappel de Versant kPCR Molecular System Sample Preparation
Rappel de e.cam system (Nuclear medicine gamma camera system )
Rappel de Cios Alpha (Portable fluoroscopic x-ray system)
Rappel de Syngo X-Workplace with software version VD10E (image processing workstation used with x-ray based diagnostic imaging system)
Rappel de Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
Rappel de AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)
Rappel de Blood Urea Nitrogen (BUN) Flex Reagent Cartridge (used with Dimension Vista System). An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Centaur Systems Calibrator E (Used with Advia Centaur, Centaur XP, Centaur XPT Systems). An in vitro diagnostic medical device (IVD)
Rappel de Berichrom Antithrombin III Kits. An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays
Rappel de BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)
Rappel de INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD)
Rappel de ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD)
Rappel de 96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)
Rappel de All Magnetom MRI systems with superconductive magnets
Rappel de ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3
Rappel de syngo X-Workplace with software VD10E and tabcard ”4D”Siemens
Rappel de ADVIA Chemistry Halogen Lamp
Rappel de ADVIA Centaur and ADVIA Centaur XP
Rappel de Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System (RMS) Dimension RxL Max HM
Rappel de Artis systems with large display module
Rappel de SOMATOM Definition AS when used with Patient table PHS1600 and software license for "Adaptive 4D Spiral"
Rappel de N Latex ß2–Microglobulin
Rappel de ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)
Rappel de ADVIA Centaur XPT. An in vitro diagnostic medical device (IVD)
Rappel de 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)
Rappel de Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMP
Rappel de AXIOM Artis FA, FC, dFA, dFC, dFCM, BA, BC, dBA, dBC, dBCM, MP, dMP systems with SW version VB23N/P
Rappel de AXIOM Artis dFA, dFC, dFCM, dBA, dBC, dBCM, dMP systems with SW version VB35D
Rappel de 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
Rappel de EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD)
Rappel de Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems)
Rappel de 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)
Rappel de Acuson 2000 ultrasound system (with structural foam core).
Rappel de Acuson SC200 ultrasound systems
Rappel de 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
Rappel de 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.
Rappel de syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD)
Rappel de Cios Alpha mobile C-arm x-ray system
Rappel de ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs
Rappel de ACUSON SC2000 ultrasound systems with software versions VB10B and lower
Rappel de ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD)
Rappel de ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo Option
Rappel de RAPIDPoint 500 Blood Gas Analyzer
Rappel de N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)(Quality control reagent)
Rappel de Dimension Creatinine and Dimension Vista Creatinine Assays
Rappel de Artis systems used in conjunction with Artis table
Rappel de Siemens e.cam Systems (Nuclear medicine gamma camera)
Rappel de Artis Q and Q.zen Floorstand and ArtisQ and Q.zen Biplane Floorstand systems with SW version VD10E
Rappel de Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
Rappel de ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines
Rappel de ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31A
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170 dispositifs dans la base de données
ARTIS Q, ARTIS pheno systems and X-ray generator
Modèle / numéro de série
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
Modèle / numéro de série
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)
Modèle / numéro de série
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
Modèle / numéro de série
ARTIS pheno systemsCatalogue Number: 10849000ARTG Number: 273952
ARTIS zee/Q systems with Large Display
Modèle / numéro de série
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
Société-mère du fabricant (2017)
Siemens AG
Source
RLMPH
Language
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