Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2020 – 31.08.2020

Опубліковано 01.09.2020 о 10:47

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  • 08.28

Urgent Field Safety Notice for Medfusion Model 3500; Medfusion Model 4000 by Smiths Medical ASD, lnc.

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF248KB

  • 08.28

Urgent Field Safety Notice for Sterile Gauze by Medline Industries, Inc

Dressings / Pads – swabs, sponges, wipes, swabsticks

PDF919KB

  • 08.27

Urgent Field Safety Notice for SpeedStitch Needle by ArthroCare Corporation Alajuela

Medical instruments for use in humans – general instruments

PDF49KB

  • 08.27

Urgent Field Safety Notice for GIEMSA SOLUTION FOR S. AUTOMATED SYSTEMS by RAL DIAGNOSTICS

In-vitro diagnostics – haematological, histological and cytological products

PDF2MB

  • 08.27

Urgent Field Safety Notice for Fujifilm Synapse PACS by FUJIFILM Medical System U.S.A., Inc.

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF127KB

  • 08.27

Urgent Field Safety Notice for DP30 LipoPlus by Nouvag AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.27

Urgent Field Safety Notice for Prosthetic foot by Streifeneder ortho.production GmbH

Orthopaedic / Rehabilitation technology – prostheses (exoprostheses)

PDF908KB

  • 08.27

Urgent Field Safety Notice for CARL Controller by Resuscitec GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 08.26

Urgent Field Safety Notice for LAP-BAND System and Accessories by apollo endosurgery

Non-active implants – special implants

PDF92KB

  • 08.26

Urgent Field Safety Notice for Velosorb Fast by Riverpoint Medical

Dressings / Pads – surgical sutures, vascular loops etc.

PDF6MB

  • 08.26

Urgent Field Safety Notice for Single RIKKI Retractor by Smith & Nephew, Inc.,

Medical instruments for use in humans – general instruments

PDF203KB

  • 08.26

Urgent Field Safety Notice for CT-Navigation system by IMACTIS

Radiological technology – navigation systems

PDF192KB

  • 08.26

Urgent Field Safety Notice for MD11 / MD30 by Nouvag AG

Dental products – dental treatment units

PDF2MB

  • 08.26

Urgent Field Safety Notice for C-RAD Gating Box HZ-009. c4D Software by C-RAD Positioning AB

Radiological technology – navigation systems

PDF401KB

  • 08.26

Urgent Field Safety Notice for ENDO GIA by Covidien llc

Medical instruments for use in humans – general instruments

PDF620KB

  • 08.26

Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

PDF132KB

  • 08.26

Urgent Field Safety Notice for Symbia S and T Series camera systems by Siemens Medical Sol. USA Inc.

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

PDF86KB

  • 08.26

Urgent Field Safety Notice for syngo.share view diagnostic by ITH icoserve technology for healthcare GmbH

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF2MB

  • 08.26

Urgent Field Safety Notice for GASTRIC TUBE by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – probes

PDF43KB

  • 08.26

Urgent Field Safety Notice for Larynx-Tubus LT by VBM Medizintechnik GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF2MB

  • 08.26

Urgent Field Safety Notice for Medumat Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF61KB

  • 08.26

Urgent Field Safety Notice for Software VeriSoft, Software BeamAdjust by PTW Freiburg, Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF64KB

  • 08.26

Urgent Field Safety Notice for MAGNEZIX CS Screws by Syntellix AG

Non-active implants – bone surgery

PDF510KB

  • 08.26

Urgent Field Safety Notice for VITROS Anti-SARS-CoV-2 Total Reagent Pack by Ortho-Clinical Diagnostics, Inc.

In-vitro diagnostics – microbiological products

PDF424KB

  • 08.26

Urgent Field Safety Notice for Gauze Swabs with X-ray Thread by Allmed Medical Products Co.,Ltd.

Dressings / Pads – dressings

PDF78K

  • 08.26

Urgent Field Safety Notice for Mammomat Revelation by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for mammographic diagnostics

PDF2MB

  • 08.26

Urgent Field Safety Notice for Optipac 60 Refobacin Bone Cement R by Biomet Orthopaedics Switzerland GmbH

Non-active implants – materials for implants

PDF2MB

  • 08.26

Urgent Field Safety Notice for LIGAMENTOTAXOR / LTX by AREX

Non-active implants – bone surgery

PDF2MB

  • 08.26

Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 08.26

Urgent Field Safety Notice for syngo.via RT Image Suite, feature: Patient marking by Siemens Healthcare GmbH, SYNGO (SY)

Radiological technology – CT scanners

PDF2MB

  • 08.26

Urgent Field Safety Notice for ALTERA by Globus Medical, Inc.

Non-active implants – bone surgery

PDF4MB

  • 08.26

Urgent Field Safety Notice for USB Download Cable -128MB used with Embletta 128 by Natus Medical Incorporated – Ontario

Medical electronics / Electromedical devices – electrodiagnostics

PDF119KB

  • 08.26

Urgent Field Safety Notice for Welch Allyn Patient Cables and Lead Sets by Welch Allyn Inc

Medical electronics / Electromedical devices – electrodiagnostics

PDF453KB

  • 08.25

Urgent Field Safety Notice for Randox Lactate Dehydrogenase L-P and P-L by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

  • 08.25

Urgent Field Safety Notice for VITROS XT3400 and XT7600 Systems by Ortho Clinical Diagnostics Inc

In-vitro diagnostics – equipment / products for clinical chemistry

PDF629KB

  • 08.25

Urgent Field Safety Notice for Novel Corona Virus COVID-19 lgM ELISA by DRG Instruments GmbH

In-vitro diagnostics – microbiological products

PDF3MB

  • 08.25

Urgent Field Safety Notice for Liaison Measles IgM by DiaSorin S.p.A.

In-vitro diagnostics – microbiological products

PDF604KB

  • 08.25

Urgent Field Safety Notice for Ammonia by Randox Laboratories Ltd GB

In-vitro diagnostics – immunological products

PDF2MB

  • 08.24

Urgent Field Safety Notice for Atellica UAS 800 analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF58KB

  • 08.24

Urgent Field Safety Notice for Accu-Chek Guide Teststreifen by Roche Diabetes Care GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF61KB

  • 08.24

Urgent Field Safety Notice for Surgical Base System by Medineering GmbH

Surgical equipment/ Anaesthesia – surgical equipment

PDF10MB

  • 08.18

Urgent Field Safety Notice for CADISS Kit by AuXin Surgery s.a.

Medical instruments for use in humans – special surgical instruments

PDF123KB

  • 08.18

Urgent Field Safety Notice for Visuref 150 by Carl-Zeiss-Meditec AG

ophthalmological technology – equipment for ophthalmological diagnostics

PDF78KB

  • 08.18

Urgent Field Safety Notice for Visulens 550 by Carl-Zeiss-Meditec AG

ophthalmological technology – equipment for ophthalmological diagnostics

PDF78KB

  • 08.18

Urgent Field Safety Notice for Medumat Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF299KB

  • 08.18

Urgent Field Safety Notice for femoral stems STEMSYS MI by EVOLUTIS SAS

Non-active implants – bone surgery

PDF1MB

  • 08.18

Urgent Field Safety Notice for Drill Sleeve Guide by AD-TECH MEDICAL INSTRUMENT CORPORATION

Medical instruments for use in humans – bone surgery

PDF328KB

  • 08.13

Urgent Field Safety Notice for Herba-Vision Augenbad plus by OTE Holding BV

ophthalmological technology – liquid media for ophthalmological purposes

PDF147KB

  • 08.13

Urgent Field Safety Notice for MobileUS by MedCom GmbH

Ultrasonics – ultrasonic diagnostic equipment

PDF102KB

  • 08.13

Urgent Field Safety Notice for LeMaitre Over-the-Wire Embolectomy Catheter by LeMaitre Vascular, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF290KB

  • 08.12

Urgent Field Safety Notice for SoKINOX/SERViNO by Maquet Critical Care AB

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF78KB

  • 08.12

Urgent Field Safety Notice for Imager II Angiographic Catheter by Boston Scientific Corporation Natick

Injections / Infusions / Transfusions / Dialysis – catheters

PDF769KB

  • 08.12

Urgent Field Safety Notice for GENESIS II NON-POROUS TIBIAL BASEPLATE by Smith & Nephew, Inc., Orthopaedics

Non-active implants – bone surgery

PDF145KB

  • 08.12

Urgent Field Safety Notice for Fructosamine by SENTINEL CH. SpA

In-vitro diagnostics – immunological products

PDF1MB

  • 08.12

Urgent Field Safety Notice for RayCare 2C SP2, 3A SP1, 3B and 4A by RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF984KB

  • 08.11

Urgent Field Safety Notice for Cortical Electrode; Depth Electrode; Anchor Bolt by AD-TECH MEDICAL INSTRUMENT CORPORATION

Medical electronics / Electromedical devices – electrotherapy

PDF239KB

  • 08.10

Urgent Field Safety Notice for ACTREEN LITE NELATON by B. Braun Medical SAS

Injections / Infusions / Transfusions / Dialysis – catheters

PDF80KB

  • 08.10

Urgent Field Safety Notice for Renuvion/J-Plasma Precise & Precise Open Handpiece by Apyx Medical Corporation

Medical electronics / Electromedical devices – electrotherapy

PDF1MB

  • 08.10

Urgent Field Safety Notice for Schlauchset, S.ülung, PC by Karl Storz S. & Co KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF112KB

  • 08.10

Urgent Field Safety Notice for HUMIDOBAC HME sterile by Andreas Fahl Medizintechnik-Vertrieb GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF139KB

  • 08.07

Urgent Field Safety Notice for G50/G60/G70/G80 Modular Patient Monitors by Philips Goldway (Shenzhen) Industrial Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF7MB

  • 08.07

Urgent Field Safety Notice for Dual collapser – size S/M by Sorin Group Italia S.r.l

Medical instruments for use in humans – cardiac/thorax surgery

PDF341KB

  • 08.07

Urgent Field Safety Notice for OFFSET CUP IMPACTOR – M8X1.25 CUP INTERFACE by INCIPIO DEVICES

Medical instruments for use in humans – bone surgery

PDF181KB

  • 08.06

Urgent Field Safety Notice for BRAHMS FT4 RIA by BRAHMS GmbH, part of Thermofisher Scientific

In-vitro diagnostics – immunological products

PDF277KB

  • 08.06

Urgent Field Safety Notice for QIAstat-Dx Respiratory SARS-CoV-2 Panel by QIAGEN GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF55KB

  • 08.06

Urgent Field Safety Notice for VITROS TBIL slides; BuBc Slides; TBIL-ALKP Slides by Ortho-Clinical Diagnostics, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF365KB

  • 08.06

Urgent Field Safety Notice for FlexLab by Inpeco SA

In-vitro diagnostics – instruments, apparatuses and systems

PDF3MB

  • 08.06

Urgent Field Safety Notice for Aptio Automation by Inpeco SA

In-vitro diagnostics – equipment / products for clinical chemistry

PDF5MB

  • 08.06

Urgent Field Safety Notice for Applied Biosystems COVID-19 Interpretive Software by Life Technologies Corporation, a part of Thermo Fisher Scientific

In-vitro diagnostics – microbiological products

PDF107KB

  • 08.05

Urgent Field Safety Notice for PROFEMUR(R) Ti and CoCr Modular Necks by MicroPort Orthopedics Inc.

Non-active implants – bone surgery

PDF152KB

  • 08.05

Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG

In-vitro diagnostics – haematological, histological and cytological products

PDF226KB

  • 08.05

Urgent Field Safety Notice for Dermalight 2000_Kombi_Modul_Zeit by Dr. Hönle Medizintechnik GmbH

Physical therapy – phototherapy

PDF183KB

  • 08.05

Urgent Field Safety Notice for FTD Viral meningitis by Fast-Track Diagnostics S.a.r.l.

In-vitro diagnostics – microbiological products

PDF181KB

  • 08.05

Urgent Field Safety Notice for Ambix Intrastick Safe Port-Kanülen by Fresenius Kabi AG

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF33KB

  • 08.05

Urgent Field Safety Notice for PROFEMUR Modular Femoral Neck Long (Ti) by MicroPort Orthopedics Inc.

Non-active implants – bone surgery

PDF147KB

  • 08.05

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF413KB

  • 08.04

Urgent Field Safety Notice for 694 AR/1 RETENTION PART SPACER 1 PC by Alphadent NV

Dental products – dental implants

PDF367KB

  • 08.04

Urgent Field Safety Notice for PRECICE BONE TRANSPORT System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc.

Active implantable medical devices – others

PDF451KB

  • 08.03

Urgent Field Safety Notice for Gyrus ACMI Smart Prostheses by Olympus Surgical Technologies America

Non-active implants – special implants

PDF489KB

  • 08.03

Urgent Field Safety Notice for Gyrus ACMI Armstrong Ventilation Tubes by Olympus Surgical Technologies America

Non-active implants – special implants

PDF494KB

  • 08.03

Urgent Field Safety Notice for Cios Alpha & Cios Spin by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – mobile radiological diagnostic facilities

PDF977KB

  • 08.03

Urgent Field Safety Notice for Fetal Blood Sampling kit by Rocket Medical plc

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF112KB

  • 08.03

Urgent Field Safety Notice for Artis zee/Artis Q by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

PDF590KB

  • 08.03

Urgent Field Safety Notice for ClearCanvas RIS/PACS by Synaptive Medical Inc

Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine

PDF297KB

  • 07.31

Urgent Field Safety Notice for Sola, Vida by Siemens Healthcare GmbH, Magnetic Resonance (MR)

Electromedical fields – equipment for MR tomography

PDF612KB

  • 07.31

Urgent Field Safety Notice for TriageHF Data Calculation Module (DCM) by Medtronic Inc

Medical data processing (software) – others

PDF29KB

  • 07.30

Urgent Field Safety Notice for SENSIS VIBE HEMO by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

PDF586KB

  • 07.30

Urgent Field Safety Notice for Protexis Latex Micro Surgical Gloves by Cardinal Health

General equipment for medical treatment – auxiliary equipment

PDF300KB

  • 07.30

Urgent Field Safety Notice for Gauze compresses with x-ray thread in Kitpack by Lohmann und Rauscher GmbH & Co. KG

Dressings / Pads – dressings

PDF41KB

  • 07.30

Urgent Field Safety Notice for OMNI II Programmer with OMNI Smart Application Sof by Impulse Dynamics (USA) Inc.

Active implantable medical devices – programming and control equipment

PDF116KB

  • 07.28

Urgent Field Safety Notice for DracoFoam (Infekt haft oder haft sensitiv) by Dr. Ausbüttel & Co. GmbH

Dressings / Pads – dressings

PDF364KB

  • 07.27

Urgent Field Safety Notice for AcoArt Orchid, AcoArt Tulip, AcoArt Litos, Orchid, Tulip, Litos by Acotec Scientific Co., Ltd.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF332KB

  • 07.27

Urgent Field Safety Notice for Kundensets by Hell & Co. GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF572KB

  • 07.24

Urgent Field Safety Notice for SICAT Implant V2.0 by SICAT GmbH & Co. KG

Medical data processing (software) – software for computer-based treatment

PDF640KB

  • 07.23

Urgent Field Safety Notice for Elecsys Anti-CCP (Modular Analytics E170, cobas e411, cobas e 601, cobas e 602, 100 tests) 05031656190. Lots: 368033, 376804, 389152, Elecsys Anti-CCP (cobas e 801, 100 tests) 072 by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF249KB

  • 07.23

Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed

Medical data processing (software) – others

PDF125KB

  • 07.23

Urgent Field Safety Notice for Elecsys Troponin T hs by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

PDF2MB

  • 07.23

Urgent Field Safety Notice for Carescape One by GE Medical Systems Information Technologies, Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF238KB

  • 07.23

Urgent Field Safety Notice for BD MAX SARS-CoV-2 Reagents by Becton, Dickinson and Company

In-vitro diagnostics – microbiological products

PDF118KB

  • 07.23

Urgent Field Safety Notice for Curve Navigation Station; Kick Navigation Station by Brainlab AG

Radiological technology – navigation systems

PDF501KB

  • 07.23

Urgent Field Safety Notice for CLINITEK Status+ Analyzer and CLINITEK Status Connect Platform by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF50KB

  • 07.22

Urgent Field Safety Notice for SynchroMed II Clinician Programmer Application by Medtronic Inc

Active implantable medical devices – drug pumps

PDF240KB

  • 07.22

Urgent Field Safety Notice for SynchroMed II Clinician Programmer Application by Medtronic Inc

Active implantable medical devices – drug pumps

PDF406KB

  • 07.22

Urgent Field Safety Notice for Primed Bakterien-/Virenfilter für Erwachsene +HME by Primed Halberstadt Medizintechnik GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF3MB

  • 07.22

Urgent Field Safety Notice for HL 40 by Maquet Critical Care AB

Surgical equipment/ Anaesthesia – surgical equipment

PDF87KB

  • 07.22

Urgent Field Safety Notice for Monnal T50 by Air Liquide Medical Systems

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF193KB

  • 07.20

Urgent Field Safety Notice for Resound, Beltone by GN Hearing A/S

Medical electronics / Electromedical devices – ENT equipment

PDF356KB

  • 07.20

Urgent Field Safety Notice for Ringer B. Braun by B. Braun Medical SAS

Physical therapy – insufflation technique

PDF64KB

  • 07.16

Urgent Field Safety Notice for MRX PT Owren’s by MediRox AB

In-vitro diagnostics – equipment / products for clinical chemistry

PDF185KB

  • 07.16

Urgent Field Safety Notice for Cios Alpha & Cios Spin by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – mobile radiological diagnostic facilities

PDF636KB

  • 07.16

Urgent Field Safety Notice for Various Biomet Products by Biomet Orthopedics, LLC

Non-active implants – bone surgery

PDF404KB

  • 07.14

Urgent Field Safety Notice for S4C CROSS CONNECTOR FIXED 22MM by Aesculap AG

Non-active implants – bone surgery

PDF1MB

  • 07.14

Urgent Field Safety Notice for Gummigebläse, für 436610 by Karl Storz S. & Co KG

Optics / Precision engineering – endoscopes

PDF96KB

  • 07.14

Urgent Field Safety Notice for Stericlin – Klarsichtbeutel aus Papier und Folie by Vereinigte Papierwarenfabriken GmbH

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF1MB

  • 07.14

Urgent Field Safety Notice for Einwegschlauchsystem ohne BiCheck Flows by WEINMANN Emergency Medical Technology GmbH + Co. KG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF529KB

  • 07.14

Urgent Field Safety Notice for Rusch GreenLite MAC (diverse Größen) by Teleflex Medical Athlone

Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)

PDF212KB

  • 07.14

Urgent Field Safety Notice for Single Use Guide Sheath Kit by Olympus Medical Systems Corp.

Optics / Precision engineering – endoscopes

PDF450KB

  • 07.14

Urgent Field Safety Notice for J-Tong by Össur hf

General equipment for medical treatment – furnishings

PDF131KB

  • 07.14

Urgent Field Safety Notice for Lifepak 500 by Physio-Control, Inc.

Medical electronics / Electromedical devices – electrotherapy

PDF96KB

  • 07.13

Urgent Field Safety Notice for Captivator/Captiflex Single-Use Polypectomy Snare by Boston Scientific Corporation Marlborough

Medical electronics / Electromedical devices – electrotherapy

PDF517KB

  • 07.09

Urgent Field Safety Notice for Carto 3 System by Biosense Webster Ltd. (Haifa, Israel)

Medical electronics / Electromedical devices – electrodiagnostics

PDF149KB

  • 07.09

Urgent Field Safety Notice for Siemens Chemistry Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF557KB

  • 07.09

Urgent Field Safety Notice for Leksell Vantage Stereotactic System by Elekta Instrument AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF382KB

  • 07.09

Urgent Field Safety Notice for Lifeguard Trolley by ArjoHuntleigh AB

General equipment for medical treatment – ward equipment and equipment for emergency medical services

PDF375KB

  • 07.08

Urgent Field Safety Notice for RAPIDPoint 500e by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF93KB

  • 07.08

Urgent Field Safety Notice for Anti C4d by Biomedica Medizinprodukte GmbH & Co KG

In-vitro diagnostics – immunological products

PDF202KB

  • 07.08

Urgent Field Safety Notice for VITROS 3600, 5600 and XT7600 Systems by Ortho-Clinical Diagnostics Inc,

In-vitro diagnostics – equipment / products for clinical chemistry

PDF496KB

  • 07.08

Urgent Field Safety Notice for Power Express, AU5800 Conn XL PW21 by Beckman Coulter, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

PDF83KB

  • 07.08

Urgent Field Safety Notice for Thermo Scientific Oxoid Dryspot Staphytect Plus by Thermo Fisher Scientific (Lenexa)

In-vitro diagnostics – microbiological products

PDF284KB

  • 07.08

Urgent Field Safety Notice for Atellica and ADVIA hsCRP Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF164KB

  • 07.08

Urgent Field Safety Notice for ABL800 with FlexQ by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF31KB

  • 07.08

Urgent Field Safety Notice for SICOLAB mini ENDO by Dürr Technik GmbH & Co KG

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF84KB

  • 07.08

Urgent Field Safety Notice for MiniCollect 9NC Coagulation Tube by Greiner Bio-One GmbH

In-vitro diagnostics – instruments, apparatuses and systems

PDF1MB

  • 07.08

Urgent Field Safety Notice for PRISCA 5 by Siemens Healthcare Diagnostics Products Ltd.

In-vitro diagnostics – instruments, apparatuses and systems

PDF51KB

  • 07.08

Urgent Field Safety Notice for MagNa Pure 96 by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF205KB

  • 07.08

Urgent Field Safety Notice for VERIGENE Reader by Luminex Corporation US

In-vitro diagnostics – equipment / products for clinical chemistry

PDF4MB

  • 07.07

Urgent Field Safety Notice for VERIGENE Processor S. by Luminex Corporation US

In-vitro diagnostics – equipment / products for clinical chemistry

PDF255KB

  • 07.07

Urgent Field Safety Notice for Uni-GoldTM S. pneumoniae by Mardx Diagnostics Inc. a Trinity Biotech Company

In-vitro diagnostics – microbiological products

PDF1,014KB

  • 07.07

Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG

In-vitro diagnostics – haematological, histological and cytological products

PDF151KB

  • 07.07

Urgent Field Safety Notice for ADVIA Centaur XP by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF227KB

  • 07.07

Urgent Field Safety Notice for DxA 5000 by Beckman Coulter Biomedical GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF81KB

  • 07.07

Urgent Field Safety Notice for Low Profile Screw, Ti, 6.7 mm x 65.0 mm, Cannulat by Arthrex INC

Non-active implants – bone surgery

PDF127KB

  • 07.07

Urgent Field Safety Notice for LEGFLOW OTW, LEGFLOW RX by Cardionovum GmbH

Injections / Infusions / Transfusions / Dialysis – catheters

PDF158KB

  • 07.07

Urgent Field Safety Notice for BD PosiFlush XS Syringe 0.9% Sodium Chloride (0.9% NaCl) 10 mL by Becton Dickinson Consumer Healthcare Europe

Injections / Infusions / Transfusions / Dialysis – catheters

PDF249KB

  • 07.03

Urgent Field Safety Notice for Infant Child Reduced Energy Electrodes by Stryker Medical

Medical electronics / Electromedical devices – electrotherapy

PDF494KB

2020.07.02

Urgent Field Safety Notice for CIMPAX ELECTRODE Conization by CIMPAX ApS

Medical electronics / Electromedical devices – electrotherapy

PDF393KB

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