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