Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2020 – 30.04.2020

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Urgent Field Safety Notice for Atellica CH Ethyl Alcohol by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics - equipment / products for clinical chemistry

PDF187KB

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

PDF80KB

Urgent Field Safety Notice for PIPELINE FLEX W/SHIELD TECHNOLOGY by Micro Therapeutics, Inc. DBA ev3 Neurovascular

Non-active implants - special implants

PDF197KB

Urgent Field Safety Notice for Corpuls 3 by GS Elektromedizinische Geräte G. Stemple GmbH

Medical electronics / Electromedical devices - electrotherapy

PDF669KB

Urgent Field Safety Notice for mint Lesion by Mint Medical GmbH

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

PDF427KB

Urgent Field Safety Notice for Mölnlycke® Procedure Trays by Mölnlycke Health Care AB

Medical instruments for use in humans - visceral surgery

PDF5MB

Urgent Field Safety Notice for HiRes Ultra / HiRes Ultra 3D by Advanced Bionics AG

Active implantable medical devices - biostimulators

PDF102KB

Urgent Field Safety Notice for Anatomical Shoulder Trial Humeral PE-Insert 40-0 by Zimmer GmbH

Medical instruments for use in humans - bone surgery

PDF2MB

Urgent Field Safety Notice for MRP- Schraube M6 by PETER BREHM GmbH

Non-active implants - bone surgery

PDF519KB

Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by Siemens Medical Solutions Diagnostics

In-vitro diagnostics - immunological products

PDF71KB

Urgent Field Safety Notice for STA Compact, STA Compact Max, STA-R Evolution, STA-R Max by Diagnostica Stago

In-vitro diagnostics - haematological, histological and cytological products

PDF138KB

Urgent Field Safety Notice for FITBONE by Wittenstein intens GmbH

Active implantable medical devices - others

PDF28KB

Urgent Field Safety Notice for Stiefenhöfer-ERCP-Katheter by medwork GmbH

Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy

PDF302KB

Urgent Field Safety Notice for FTD FLU/HRSV by Fast-Track Diagnostics S.a.r.l.

In-vitro diagnostics - microbiological products

PDF116KB

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

In-vitro diagnostics - equipment / products for clinical chemistry

PDF2MB

Urgent Field Safety Notice for Idylla EGFR Mutation Test by Biocartis

In-vitro diagnostics - immunological products

PDF8MB

Urgent Field Safety Notice for EXTREME monobloc Epiphyseal-Metaphyseal with HAP by Amplitude S.A.S.

Non-active implants - bone surgery

PDF592KB

Urgent Field Safety Notice for Anti-Zika-Virus-ELISA (IgG) by EUROIMMUN Medizinische Labordiagnostika AG

In-vitro diagnostics - microbiological products

PDF22KB

Urgent Field Safety Notice for GEM Microvascular Anastomotic Coupler by Synovis Micro Companies Alliance, Inc.

Non-active implants - special implants

PDF79KB

Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Strips by Beckman Coulter Ireland Inc.

In-vitro diagnostics - equipment / products for clinical chemistry

PDF125KB

Urgent Field Safety Notice for B·R·A·H·M·S uE3 KRYPTOR by BRAHMS GmbH, part of Thermofisher Scientific

In-vitro diagnostics - immunological products

PDF5MB

Urgent Field Safety Notice for VIDAS NT-proBNP2 by bioMérieux S. (Marcy- l'Etoile)

In-vitro diagnostics - immunological products

PDF144KB

Urgent Field Safety Notice for Finger Spreader by Maillefer Instruments Holding SARL

Dental products - instruments

PDF100KB

Urgent Field Safety Notice for MultiPulse HoPLUS by Asclepion Laser Technologies GmbH

Optics / Precision engineering - laser technology

PDF1MB

Urgent Field Safety Notice for LogiCal Pressure Monitoring Kit by Smiths Medical ASD, Inc. (Plymouth)

Medical electronics / Electromedical devices - electronic blood pressure monitor

PDF280KB

Urgent Field Safety Notice for MELAdes 800, MELAdes 801 by Melag oHG Medizintechnik

General equipment for medical treatment - cleaning / disinfection / sterilisation

PDF4MB

Urgent Field Safety Notice for MARS Treatment Kit by Gambro Lundia AB

Injections / Infusions / Transfusions / Dialysis - dialysis technology

PDF110KB

Urgent Field Safety Notice for TSC PLIF by Orthobion GmbH

Non-active implants - bone surgery

PDF608KB

Urgent Field Safety Notice for TIVA Infusionssystem 2 by Shandong Lee Med Technology Co., Ltd.

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF301KB

Urgent Field Safety Notice for Direct Bilirubin and Total Bilirubin Assays by Siemens Healthcare Diagnostics Inc. Newark

In-vitro diagnostics - equipment / products for clinical chemistry

PDF136KB

Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB

Injections / Infusions / Transfusions / Dialysis - dialysis technology

PDF128KB

Urgent Field Safety Notice for NeuraGen Nerve Guide by Integra LifeSciences Corporation

Non-active implants - other implants

PDF737KB

Urgent Field Safety Notice for Arrow Multiple-Lumen Catheter by Teleflex Medical USA

Injections / Infusions / Transfusions / Dialysis - catheters

PDF157KB

Urgent Field Safety Notice for sona Aspergillus GM Lateral Flow Assay by Immy

In-vitro diagnostics - microbiological products

PDF181KB

Urgent Field Safety Notice for newbio pk TPHA 2000 by Newmarket Laboratories Ltd.

In-vitro diagnostics - microbiological products

PDF164KB

Urgent Field Safety Notice for Dade Ci-Trol 1 by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics - haematological, histological and cytological products

PDF78KB

Urgent Field Safety Notice for Damon Q2 by Ormco Corporation

Dental products - orthodontic equipment

PDF121KB

Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS

In-vitro diagnostics - equipment / products for clinical chemistry

PDF189KB

Urgent Field Safety Notice for Snaplink Buccal Tube, 18° 0° 12° by Ormco Corporation

Dental products - orthodontic equipment

PDF218KB

Urgent Field Safety Notice for Olympus Diego Elite High speed drill burrs by Olympus Surgical Technologies America

Medical instruments for use in humans - bone surgery

PDF447KB

Urgent Field Safety Notice for Purified silicon oil by FCI S.A.S.

Injections / Infusions / Transfusions / Dialysis - syringes and cannulas

PDF268KB

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.

Active implantable medical devices - artificial hearts

PDF456KB

Urgent Field Safety Notice for StageOne Select, Hip Cement Spacer Molds by Biomet Orthopedics, LLC

Non-active implants - materials for implants

PDF231KB

Urgent Field Safety Notice for Medilas H140 by Dornier MedTech Systems GmbH

Optics / Precision engineering - laser technology

PDF7MB

Urgent Field Safety Notice for SwiftHook by Handicare AB Sweden

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

PDF16MB

Urgent Field Safety Notice for Sensor Nitinol Guidewires with Hydrophylic Tip by Boston Scientific Corporation Marlborough

Injections / Infusions / Transfusions / Dialysis - catheters

PDF721KB

Urgent Field Safety Notice for Estradiol by Demeditec Diagnostics GmbH

In-vitro diagnostics - immunological products

PDF2MB

Urgent Field Safety Notice for Epix latis Grasper by Applied Medical Resources

Optics / Precision engineering - endoscopes

PDF195KB

Urgent Field Safety Notice for MICRO SCISSORS CVD.BL/SH 140MM by Aesculap AG

Medical instruments for use in humans - general instruments

PDF711KB

Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare

Medical electronics / Electromedical devices - electrotherapy

PDF520KB

Urgent Field Safety Notice for FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 by Smith & Nephew, Inc. Endoscopy Division

Non-active implants - bone surgery

PDF100KB

Urgent Field Safety Notice for TRx4851A 2.4 GHz / TRx4841A 1.4GHz IntelliVue Tel. by Philips Medical Systems

Medical electronics / Electromedical devices - electrodiagnostics

PDF1MB

Urgent Field Safety Notice for Meddstone by Stille AB

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

PDF175KB

Urgent Field Safety Notice for Matoset by Torunskie Zaklady Materialów Opatrunkowych SA

Medical instruments for use in humans - general instruments

PDF192KB

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Radiotherapy / Radiation protection - radiotherapy treatment planning systems

PDF331KB

Urgent Field Safety Notice for NAVIO Soft Tissue Protector by Smith & Nephew Inc. (Plymouth)

Medical instruments for use in humans - bone surgery

PDF235KB

Urgent Field Safety Notice for Protective Cover of Vivo 55/65 by Breas Medical AB

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF65KB

Urgent Field Safety Notice for VANTRIS VUR Treatment by Promedon S.A.

Non-active implants - special implants

PDF110KB

Urgent Field Safety Notice for Combilite by GCE s.r.o.

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF1MB

Urgent Field Safety Notice for Elecsys CA 19-9 by Roche Diagnostics GmbH

In-vitro diagnostics - immunological products

PDF293KB

Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics - equipment / products for clinical chemistry

PDF51KB

Urgent Field Safety Notice for Multilevel Plasma Calibrator Set Neuroleptics 1 by Chromsystems Instruments & Chemicals GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF4MB

Urgent Field Safety Notice for MiniCollect® TUBE 1 ml 9NC 3,8% by Greiner Bio-One GmbH

In-vitro diagnostics - instruments, apparatuses and systems

PDF2MB

Urgent Field Safety Notice for GreenLight MoXy Fiber Optic by American Medical Systems, Inc.

Optics / Precision engineering - laser technology

PDF464KB

Urgent Field Safety Notice for VITEK 2 AST-N371 by bioMérieux Inc

In-vitro diagnostics - microbiological products

PDF784KB

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

Radiological technology - navigation systems

PDF1MB

Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics - equipment / products for clinical chemistry

PDF533KB

Urgent Field Safety Notice for AnaConDa by Sedana Medical AB

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF60KB

Urgent Field Safety Notice for CORFLO* PEG Kit with ENFit Connector by Avanos Medical Inc

Injections / Infusions / Transfusions / Dialysis - probes

PDF187KB

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

Injections / Infusions / Transfusions / Dialysis - catheters

PDF273KB

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

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

PDF222KB

Urgent Field Safety Notice for Langston Dual Lumen Pigtail Catheter by Vascular Solutions, Inc.

Injections / Infusions / Transfusions / Dialysis - catheters

PDF214KB

Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V.

Radiological technology - radiological equipment for vascular diagnostics

PDF167KB

Urgent Field Safety Notice for Charging Unit mounted T DC TS 7500 by TRUMPF Medizin Systeme GmbH + Co. KG

Surgical equipment/ Anaesthesia - surgical equipment

PDF81KB

Urgent Field Safety Notice for Servona Silver Cannulas (REF various) by Servona GmbH

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF250KB

Urgent Field Safety Notice for Pump Kit, CADD SOLIS VIP MDL 2120 by Smiths Medical ASD, Inc. (Plymouth)

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF457KB

Urgent Field Safety Notice for Endo-Model Knee Fusion Nail, Femoral, left, Size 1 by Waldemar Link GmbH & Co. KG

Non-active implants - bone surgery

PDF3MB

Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB

Injections / Infusions / Transfusions / Dialysis - dialysis technology

PDF39KB

Urgent Field Safety Notice for Aptio Automation by Inpeco SA

In-vitro diagnostics - equipment / products for clinical chemistry

PDF2MB

Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA

In-vitro diagnostics - equipment / products for clinical chemistry

PDF3MB

Urgent Field Safety Notice for Easy Life & Easy Life T by Sunrise Medical GmbH & Co. KG

Orthopaedic / Rehabilitation technology - mobility aids

PDF1MB

Urgent Field Safety Notice for RTest 4 Evolution by Novacor SAS

Medical electronics / Electromedical devices - electrodiagnostics

PDF254KB

Urgent Field Safety Notice for CompoStop by Fresenius Kabi Deutschland GmbH

Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells

PDF61KB

Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.

Active implantable medical devices - artificial hearts

PDF502KB

Urgent Field Safety Notice for VivaDiag COVID-19 lgM/ IgG Rapid Test by VivaChek Laboratories, Inc.

In-vitro diagnostics - microbiological products

PDF1MB

Urgent Field Safety Notice for Alere Afinion 2, Afinion 2, Alere Afinion AS100 by Abbott Diagnostics Technologies AS

In-vitro diagnostics - haematological, histological and cytological products

PDF188KB

Urgent Field Safety Notice for Epstein- Barr virus EA IgM ELISA by IBL International GmbH

In-vitro diagnostics - immunological products

PDF50KB

Urgent Field Safety Notice for KWIK-STIK Trichosporon dermatis & KWIK-STIK YST by Microbiologics

In-vitro diagnostics - microbiological products

PDF150KB

Urgent Field Safety Notice for Normal Range Trace Elements Control by UTAK Laboratories

In-vitro diagnostics - equipment / products for clinical chemistry

PDF521KB

Urgent Field Safety Notice for Monnal EVA expiratory s.t. - Single Use version (UU) and Expiratory Valve membrane by Air Liquide Medical Systems

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF181KB

Urgent Field Safety Notice for OZONOSAN Keimstop by Dr. J. Hänsler GmbH

Injections / Infusions / Transfusions / Dialysis - infusion kits

PDF790KB

Urgent Field Safety Notice for HEMASHIELD GOLD - HEMASHIELD PLATINUM by InterVascular S.A.S

Non-active implants - special implants

PDF248KB

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

Radiological technology - mobile radiological diagnostic facilities

PDF2MB

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

Medical electronics / Electromedical devices - electrodiagnostics

PDF100KB

Urgent Field Safety Notice for Optilite Analyser by The Binding Site Group Limited

In-vitro diagnostics - equipment / products for clinical chemistry

PDF341KB

Urgent Field Safety Notice for TR9650 by TR Equipment AB

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

PDF685KB

Urgent Field Safety Notice for therascreen EGFR RGQ PCR Kit (24), V2 and therascreen EGFR Plasma RGQ PCR Kit (24) by QIAGEN GmbH

In-vitro diagnostics - immunological products

PDF125KB

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

In-vitro diagnostics - microbiological products

PDF187KB

Urgent Field Safety Notice for Presage ST2 Assay by Critical Diagnostics

In-vitro diagnostics - haematological, histological and cytological products

PDF601KB

Urgent Field Safety Notice for FlexLab by Inpeco SA

In-vitro diagnostics - instruments, apparatuses and systems

PDF3MB

Urgent Field Safety Notice for Corpuls CPR by GS Elektromedizinische Geräte G. Stemple GmbH

Medical electronics / Electromedical devices - electrotherapy

PDF190KB

Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies

Radiological technology - radiological equipment for vascular diagnostics

PDF679KB

Urgent Field Safety Notice for Q 700 by Sunrise Medical GmbH & Co. KG

Orthopaedic / Rehabilitation technology - mobility aids

PDF2MB

Urgent Field Safety Notice for Bridge Occlusion Balloon by Spectranetics Corporation

Injections / Infusions / Transfusions / Dialysis - catheters

PDF124KB

Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Analyzer,iQ200 Urine Microscopy Analyzer by Beckman Coulter Ireland Inc.

In-vitro diagnostics - equipment / products for clinical chemistry

PDF100KB

Urgent Field Safety Notice for Anti-Parvovirus-B19-ELISA (IgM) by EUROIMMUN Medizinische Labordiagnostika AG

In-vitro diagnostics - microbiological products

PDF56KB

Urgent Field Safety Notice for Dade Actin Activated Cephaloplastin Reagent by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics - haematological, histological and cytological products

PDF67KB

Urgent Field Safety Notice for Creatinine PAP FS by DiaSys Diagnostic Systems GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF444KB

Urgent Field Safety Notice for MicroScan LabPro Information Manager System by Beckman Coulter, Inc.

In-vitro diagnostics - microbiological products

PDF1MB

Urgent Field Safety Notice for Artis icono by Siemens Healthcare GmbH Advanced Therapies

Radiological technology - radiological equipment for vascular diagnostics

PDF1MB

Urgent Field Safety Notice for KLS Martin / smartDrive by Gebrüder Martin GmbH & Co. KG

Medical instruments for use in humans - bone surgery

PDF432KB

Urgent Field Safety Notice for CAMILINO by AAT Alber Antriebstechnik GmbH

Orthopaedic / Rehabilitation technology - mobility aids

PDF71KB

Urgent Field Safety Notice for BeGraft Coronary Stent Graft System by Bentley InnoMed GmbH

Non-active implants - special implants

PDF2MB

Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.

Radiological technology - stationary radiological equipment

PDF163KB

Urgent Field Safety Notice for Infect/Cardio CRP by concile GmbH

In-vitro diagnostics - immunological products

PDF486KB

Urgent Field Safety Notice for Comprehensive Reverse Shoulder System by Biomet Orthopedics, LLC

Non-active implants - bone surgery

PDF401KB

Urgent Field Safety Notice for IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5 by Ivoclar Vivadent AG

Dental products - dental material

PDF146KB

Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH & Co. KG

In-vitro diagnostics - equipment / products for clinical chemistry

PDF151KB

Urgent Field Safety Notice for Plasmaprotelns Cal 3x. Plasmaproteins Cal by SENTINEL CH. SpA

In-vitro diagnostics - equipment / products for clinical chemistry

PDF9MB

Urgent Field Safety Notice for Armstrong Medical Catheter Mounts by Armstrong Medical Ltd.

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF218KB

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

Radiological technology - mobile radiological diagnostic facilities

PDF2MB

Urgent Field Safety Notice for lmmuno Control Set by SENTINEL CH. SpA

In-vitro diagnostics - equipment / products for clinical chemistry

PDF6MB

Urgent Field Safety Notice for SCOUT Guide and SCOUT CHECK Handpiece by Merit Medical Systems Inc.

Surgical equipment/ Anaesthesia - surgical equipment

PDF796KB

Urgent Field Safety Notice for Bilirubin und Creatinine Tests (Bilirubin Auto Direct FS/Total FS; Creatinine FS/PAP FS) by DiaSys Diagnostic Systems GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF369KB

Urgent Field Safety Notice for SpeedSurg Steuereinheit by Spiggle & Theis Medizintechnik GmbH

Surgical equipment/ Anaesthesia - surgical equipment

PDF824KB

Urgent Field Safety Notice for Compact 5 by DeVilbiss Healthcare Ltd.

Physical therapy - equipment for oxygen therapy

PDF569KB

Urgent Field Safety Notice for Eleganza 5 by Linet spol. S..o.

General equipment for medical treatment - furnishings

PDF227KB

Urgent Field Safety Notice for SCHILLER medilog DARWIN by Schiller AG

Medical electronics / Electromedical devices - electrodiagnostics

PDF14MB

Urgent Field Safety Notice for Coagulation Factor V Deficient Plasma by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics - haematological, histological and cytological products

PDF142KB

Urgent Field Safety Notice for N Latex CDT OPCS by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics - immunological products

PDF66KB

Urgent Field Safety Notice for AQT90 FLEX Analyzer by Radiometer Medical ApS

In-vitro diagnostics - equipment / products for clinical chemistry

PDF89KB