Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.03.2020 – 30.04.2020
Опубліковано 01.05.2020 о 13:51- 03.02
Urgent Field Safety Notice for Atellica CH Ethyl Alcohol by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.02
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
- 03.03
Urgent Field Safety Notice for PIPELINE FLEX W/SHIELD TECHNOLOGY by Micro Therapeutics, Inc. DBA ev3 Neurovascular
Non-active implants – special implants
- 03.03
Urgent Field Safety Notice for Corpuls 3 by GS Elektromedizinische Geräte G. Stemple GmbH
Medical electronics / Electromedical devices – electrotherapy
- 03.03
Urgent Field Safety Notice for mint Lesion by Mint Medical GmbH
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
- 03.02
Urgent Field Safety Notice for Mölnlycke® Procedure Trays by Mölnlycke Health Care AB
Medical instruments for use in humans – visceral surgery
- 03.02
Urgent Field Safety Notice for HiRes Ultra / HiRes Ultra 3D by Advanced Bionics AG
Active implantable medical devices – biostimulators
- 03.02
Urgent Field Safety Notice for Anatomical Shoulder Trial Humeral PE-Insert 40-0 by Zimmer GmbH
Medical instruments for use in humans – bone surgery
- 03.02
Urgent Field Safety Notice for MRP- Schraube M6 by PETER BREHM GmbH
Non-active implants – bone surgery
- 03.02
Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by Siemens Medical Solutions Diagnostics
In-vitro diagnostics – immunological products
- 03.02
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
- 03.02
Urgent Field Safety Notice for FITBONE by Wittenstein intens GmbH
Active implantable medical devices – others
- 03.02
Urgent Field Safety Notice for Stiefenhöfer-ERCP-Katheter by medwork GmbH
Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
- 03.02
Urgent Field Safety Notice for FTD FLU/HRSV by Fast-Track Diagnostics S.a.r.l.
In-vitro diagnostics – microbiological products
- 03.02
Urgent Field Safety Notice for DxA 5000 by Beckman Coulter Biomedical GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.02
Urgent Field Safety Notice for Idylla EGFR Mutation Test by Biocartis
In-vitro diagnostics – immunological products
- 03.02
Urgent Field Safety Notice for EXTREME monobloc Epiphyseal-Metaphyseal with HAP by Amplitude S.A.S.
Non-active implants – bone surgery
- 03.11
Urgent Field Safety Notice for Anti-Zika-Virus-ELISA (IgG) by EUROIMMUN Medizinische Labordiagnostika AG
In-vitro diagnostics – microbiological products
- 03.11
Urgent Field Safety Notice for GEM Microvascular Anastomotic Coupler by Synovis Micro Companies Alliance, Inc.
Non-active implants – special implants
- 03.11
Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Strips by Beckman Coulter Ireland Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.11
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
- 03.11
Urgent Field Safety Notice for VIDAS NT-proBNP2 by bioMérieux S. (Marcy- l’Etoile)
In-vitro diagnostics – immunological products
- 03.10
Urgent Field Safety Notice for Finger Spreader by Maillefer Instruments Holding SARL
Dental products – instruments
- 03.10
Urgent Field Safety Notice for MultiPulse HoPLUS by Asclepion Laser Technologies GmbH
Optics / Precision engineering – laser technology
- 03.10
Urgent Field Safety Notice for LogiCal Pressure Monitoring Kit by Smiths Medical ASD, Inc. (Plymouth)
Medical electronics / Electromedical devices – electronic blood pressure monitor
- 03.10
Urgent Field Safety Notice for MELAdes 800, MELAdes 801 by Melag oHG Medizintechnik
General equipment for medical treatment – cleaning / disinfection / sterilisation
- 03.06
Urgent Field Safety Notice for MARS Treatment Kit by Gambro Lundia AB
Injections / Infusions / Transfusions / Dialysis – dialysis technology
- 03.05
Urgent Field Safety Notice for TSC PLIF by Orthobion GmbH
Non-active implants – bone surgery
- 03.05
Urgent Field Safety Notice for TIVA Infusionssystem 2 by Shandong Lee Med Technology Co., Ltd.
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 03.03
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
- 03.03
Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
Injections / Infusions / Transfusions / Dialysis – dialysis technology
- 03.03
Urgent Field Safety Notice for NeuraGen Nerve Guide by Integra LifeSciences Corporation
Non-active implants – other implants
- 03.18
Urgent Field Safety Notice for Arrow Multiple-Lumen Catheter by Teleflex Medical USA
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.18
Urgent Field Safety Notice for sona Aspergillus GM Lateral Flow Assay by Immy
In-vitro diagnostics – microbiological products
- 03.18
Urgent Field Safety Notice for newbio pk TPHA 2000 by Newmarket Laboratories Ltd.
In-vitro diagnostics – microbiological products
- 03.18
Urgent Field Safety Notice for Dade Ci-Trol 1 by Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – haematological, histological and cytological products
- 03.18
Urgent Field Safety Notice for Damon Q2 by Ormco Corporation
Dental products – orthodontic equipment
- 03.18
Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.18
Urgent Field Safety Notice for Snaplink Buccal Tube, 18° 0° 12° by Ormco Corporation
Dental products – orthodontic equipment
- 03.16
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
- 03.16
Urgent Field Safety Notice for Purified silicon oil by FCI S.A.S.
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
- 03.13
Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
Active implantable medical devices – artificial hearts
- 03.13
Urgent Field Safety Notice for StageOne Select, Hip Cement Spacer Molds by Biomet Orthopedics, LLC
Non-active implants – materials for implants
- 03.12
Urgent Field Safety Notice for Medilas H140 by Dornier MedTech Systems GmbH
Optics / Precision engineering – laser technology
- 03.11
Urgent Field Safety Notice for SwiftHook by Handicare AB Sweden
General equipment for medical treatment – ward equipment and equipment for emergency medical services
- 03.11
Urgent Field Safety Notice for Sensor Nitinol Guidewires with Hydrophylic Tip by Boston Scientific Corporation Marlborough
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.11
Urgent Field Safety Notice for Estradiol by Demeditec Diagnostics GmbH
In-vitro diagnostics – immunological products
- 03.26
Urgent Field Safety Notice for Epix latis Grasper by Applied Medical Resources
Optics / Precision engineering – endoscopes
- 03.25
Urgent Field Safety Notice for MICRO SCISSORS CVD.BL/SH 140MM by Aesculap AG
Medical instruments for use in humans – general instruments
- 03.25
Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare
Medical electronics / Electromedical devices – electrotherapy
- 03.25
Urgent Field Safety Notice for FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5 by Smith & Nephew, Inc. Endoscopy Division
Non-active implants – bone surgery
- 03.23
Urgent Field Safety Notice for TRx4851A 2.4 GHz / TRx4841A 1.4GHz IntelliVue Tel. by Philips Medical Systems
Medical electronics / Electromedical devices – electrodiagnostics
- 03.23
Urgent Field Safety Notice for Meddstone by Stille AB
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
- 03.23
Urgent Field Safety Notice for Matoset by Torunskie Zaklady Materialów Opatrunkowych SA
Medical instruments for use in humans – general instruments
- 03.20
Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
- 03.20
Urgent Field Safety Notice for NAVIO Soft Tissue Protector by Smith & Nephew Inc. (Plymouth)
Medical instruments for use in humans – bone surgery
- 03.19
Urgent Field Safety Notice for Protective Cover of Vivo 55/65 by Breas Medical AB
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.19
Urgent Field Safety Notice for VANTRIS VUR Treatment by Promedon S.A.
Non-active implants – special implants
- 03.19
Urgent Field Safety Notice for Combilite by GCE s.r.o.
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.19
Urgent Field Safety Notice for Elecsys CA 19-9 by Roche Diagnostics GmbH
In-vitro diagnostics – immunological products
- 03.18
Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.18
Urgent Field Safety Notice for Multilevel Plasma Calibrator Set Neuroleptics 1 by Chromsystems Instruments & Chemicals GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.08
Urgent Field Safety Notice for MiniCollect® TUBE 1 ml 9NC 3,8% by Greiner Bio-One GmbH
In-vitro diagnostics – instruments, apparatuses and systems
- 04.08
Urgent Field Safety Notice for GreenLight MoXy Fiber Optic by American Medical Systems, Inc.
Optics / Precision engineering – laser technology
- 04.08
Urgent Field Safety Notice for VITEK 2 AST-N371 by bioMérieux Inc
In-vitro diagnostics – microbiological products
- 04.08
Urgent Field Safety Notice for C-RAD Gating Box HZ-009. c4D Software by C-RAD Positioning AB
Radiological technology – navigation systems
- 04.08
Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.01
Urgent Field Safety Notice for AnaConDa by Sedana Medical AB
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.31
Urgent Field Safety Notice for CORFLO* PEG Kit with ENFit Connector by Avanos Medical Inc
Injections / Infusions / Transfusions / Dialysis – probes
- 03.30
Urgent Field Safety Notice for LeMaitre Over-the-Wire Embolectomy Catheter by LeMaitre Vascular, Inc.
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.30
Urgent Field Safety Notice for ClearCanvas RIS/PACS by Synaptive Medical Inc
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
- 03.30
Urgent Field Safety Notice for Langston Dual Lumen Pigtail Catheter by Vascular Solutions, Inc.
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.30
Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V.
Radiological technology – radiological equipment for vascular diagnostics
- 03.30
Urgent Field Safety Notice for Charging Unit mounted T DC TS 7500 by TRUMPF Medizin Systeme GmbH + Co. KG
Surgical equipment/ Anaesthesia – surgical equipment
- 03.30
Urgent Field Safety Notice for Servona Silver Cannulas (REF various) by Servona GmbH
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.27
Urgent Field Safety Notice for Pump Kit, CADD SOLIS VIP MDL 2120 by Smiths Medical ASD, Inc. (Plymouth)
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 03.26
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
- 04.15
Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
Injections / Infusions / Transfusions / Dialysis – dialysis technology
- 04.15
Urgent Field Safety Notice for Aptio Automation by Inpeco SA
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.15
Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.15
Urgent Field Safety Notice for Easy Life & Easy Life T by Sunrise Medical GmbH & Co. KG
Orthopaedic / Rehabilitation technology – mobility aids
- 04.14
Urgent Field Safety Notice for RTest 4 Evolution by Novacor SAS
Medical electronics / Electromedical devices – electrodiagnostics
- 04.09
Urgent Field Safety Notice for CompoStop by Fresenius Kabi Deutschland GmbH
Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
- 04.09
Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
Active implantable medical devices – artificial hearts
- 04.09
Urgent Field Safety Notice for VivaDiag COVID-19 lgM/ IgG Rapid Test by VivaChek Laboratories, Inc.
In-vitro diagnostics – microbiological products
- 04.09
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
- 04.09
Urgent Field Safety Notice for Epstein- Barr virus EA IgM ELISA by IBL International GmbH
In-vitro diagnostics – immunological products
- 04.09
Urgent Field Safety Notice for KWIK-STIK Trichosporon dermatis & KWIK-STIK YST by Microbiologics
In-vitro diagnostics – microbiological products
- 04.08
Urgent Field Safety Notice for Normal Range Trace Elements Control by UTAK Laboratories
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.08
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
- 04.08
Urgent Field Safety Notice for OZONOSAN Keimstop by Dr. J. Hänsler GmbH
Injections / Infusions / Transfusions / Dialysis – infusion kits
- 04.08
Urgent Field Safety Notice for HEMASHIELD GOLD – HEMASHIELD PLATINUM by InterVascular S.A.S
Non-active implants – special implants
- 04.21
Urgent Field Safety Notice for Cios Alpha & Cios Spion by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – mobile radiological diagnostic facilities
- 04.21
Urgent Field Safety Notice for Welch Allyn Patient Cables and Lead Sets by Welch Allyn Inc
Medical electronics / Electromedical devices – electrodiagnostics
- 04.21
Urgent Field Safety Notice for Optilite Analyser by The Binding Site Group Limited
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.20
Urgent Field Safety Notice for TR9650 by TR Equipment AB
General equipment for medical treatment – ward equipment and equipment for emergency medical services
- 04.17
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
- 04.17
Urgent Field Safety Notice for FTD Vesicular rash by Fast-Track Diagnostics S.a.r.l.
In-vitro diagnostics – microbiological products
- 04.17
Urgent Field Safety Notice for Presage ST2 Assay by Critical Diagnostics
In-vitro diagnostics – haematological, histological and cytological products
- 04.17
Urgent Field Safety Notice for FlexLab by Inpeco SA
In-vitro diagnostics – instruments, apparatuses and systems
- 04.16
Urgent Field Safety Notice for Corpuls CPR by GS Elektromedizinische Geräte G. Stemple GmbH
Medical electronics / Electromedical devices – electrotherapy
- 04.16
Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – radiological equipment for vascular diagnostics
- 04.15
Urgent Field Safety Notice for Q 700 by Sunrise Medical GmbH & Co. KG
Orthopaedic / Rehabilitation technology – mobility aids
- 04.15
Urgent Field Safety Notice for Bridge Occlusion Balloon by Spectranetics Corporation
Injections / Infusions / Transfusions / Dialysis – catheters
- 04.15
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
- 04.15
Urgent Field Safety Notice for Anti-Parvovirus-B19-ELISA (IgM) by EUROIMMUN Medizinische Labordiagnostika AG
In-vitro diagnostics – microbiological products
- 04.15
Urgent Field Safety Notice for Dade Actin Activated Cephaloplastin Reagent by Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – haematological, histological and cytological products
- 04.28
Urgent Field Safety Notice for Creatinine PAP FS by DiaSys Diagnostic Systems GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.28
Urgent Field Safety Notice for MicroScan LabPro Information Manager System by Beckman Coulter, Inc.
In-vitro diagnostics – microbiological products
- 04.27
Urgent Field Safety Notice for Artis icono by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – radiological equipment for vascular diagnostics
- 04.27
Urgent Field Safety Notice for KLS Martin / smartDrive by Gebrüder Martin GmbH & Co. KG
Medical instruments for use in humans – bone surgery
- 04.27
Urgent Field Safety Notice for CAMILINO by AAT Alber Antriebstechnik GmbH
Orthopaedic / Rehabilitation technology – mobility aids
- 04.23
Urgent Field Safety Notice for BeGraft Coronary Stent Graft System by Bentley InnoMed GmbH
Non-active implants – special implants
- 04.23
Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.
Radiological technology – stationary radiological equipment
- 04.23
Urgent Field Safety Notice for Infect/Cardio CRP by concile GmbH
In-vitro diagnostics – immunological products
- 04.23
Urgent Field Safety Notice for Comprehensive Reverse Shoulder System by Biomet Orthopedics, LLC
Non-active implants – bone surgery
- 04.23
Urgent Field Safety Notice for IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5 by Ivoclar Vivadent AG
Dental products – dental material
- 04.23
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
- 04.22
Urgent Field Safety Notice for Plasmaprotelns Cal 3x. Plasmaproteins Cal by SENTINEL CH. SpA
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.21
Urgent Field Safety Notice for Armstrong Medical Catheter Mounts by Armstrong Medical Ltd.
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 04.21
Urgent Field Safety Notice for Cios Alpha & Cios Spion by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – mobile radiological diagnostic facilities
- 04.21
Urgent Field Safety Notice for lmmuno Control Set by SENTINEL CH. SpA
In-vitro diagnostics – equipment / products for clinical chemistry
- 04.29
Urgent Field Safety Notice for SCOUT Guide and SCOUT CHECK Handpiece by Merit Medical Systems Inc.
Surgical equipment/ Anaesthesia – surgical equipment
- 04.29
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
- 04.29
Urgent Field Safety Notice for SpeedSurg Steuereinheit by Spiggle & Theis Medizintechnik GmbH
Surgical equipment/ Anaesthesia – surgical equipment
- 04.29
Urgent Field Safety Notice for Compact 5 by DeVilbiss Healthcare Ltd.
Physical therapy – equipment for oxygen therapy
- 04.29
Urgent Field Safety Notice for Eleganza 5 by Linet spol. S..o.
General equipment for medical treatment – furnishings
- 04.29
Urgent Field Safety Notice for SCHILLER medilog DARWIN by Schiller AG
Medical electronics / Electromedical devices – electrodiagnostics
- 04.28
Urgent Field Safety Notice for Coagulation Factor V Deficient Plasma by Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – haematological, histological and cytological products
- 04.28
Urgent Field Safety Notice for N Latex CDT OPCS by Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – immunological products
- 04.28
Urgent Field Safety Notice for AQT90 FLEX Analyzer by Radiometer Medical ApS
In-vitro diagnostics – equipment / products for clinical chemistry
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