Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2020 – 29.02.2020
Опубліковано 02.03.2020 о 13:34- 01.09
Urgent Field Safety Notice for Arrow PICC, Epiduralkatheter, Abdecktuch, Nadel für kontinuierliche Nervenblockade etc. by Arrow International Inc.
Injections / Infusions / Transfusions / Dialysis – other products for injections / infusions / transfusions / dialysis
- 01.09
Urgent Field Safety Notice for CTG7 fetal/maternal monitor by Philips Goldway (Shenzhen) Industrial Inc.
Medical electronics / Electromedical devices – electrodiagnostics
- 01.08
Urgent Field Safety Notice for Basissets mit Papp-Nierenschalen by Smiths Medical ASD, Inc. (Plymouth)
Dressings / Pads – others
- 01.07
Urgent Field Safety Notice for Bronchoscope by Olympus Medical Systems Corp.
Optics / Precision engineering – endoscopes
- 01.07
Urgent Field Safety Notice for All Linacs with COHERENCE ONCOLOGIST RT* by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
- 01.07
Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V.
Radiological technology – radiological equipment for vascular diagnostics
- 01.06
Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – radiological equipment for vascular diagnostics
- 01.06
Urgent Field Safety Notice for Centricity Universal Viewer by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc
Medical data processing (software) – data processing facilities for image processing
- 01.06
Urgent Field Safety Notice for IDRT – Single Layer and IDRT TS by Integra LifeSciences Corporation
Non-active implants – special implants
- 01.06
Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc
Physical therapy – climatotherapy
- 01.06
Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS
Medical electronics / Electromedical devices – electrotherapy
- 01.06
Urgent Field Safety Notice for CorPatch easy by Leonhard Lang Medizintechnik GmbH
Medical electronics / Electromedical devices – electrotherapy
- 01.06
Urgent Field Safety Notice for PatientOnLine by Fresenius Medical Care AG & Co. KGaA
Injections / Infusions / Transfusions / Dialysis – dialysis technology
- 01.06
Urgent Field Safety Notice for Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep by Mavidon
Medical electronics / Electromedical devices – electrodiagnostics
- 01.15
Urgent Field Safety Notice for 8 mm Endoscope and Camera Head Sterilization Tray by Intuitive Surgical, Inc.
General equipment for medical treatment – cleaning / disinfection / sterilisation
- 01.15
Urgent Field Safety Notice for GORE EXCLUDER AAA Endoprosthesis & GORE IBE by W.L. Gore & Associates, Inc.
Non-active implants – special implants
- 01.15
Urgent Field Safety Notice for Aequalis Ascend Flex Shoulder System by TORNIER SAS
Non-active implants – bone surgery
- 01.15
Urgent Field Safety Notice for Closed Suction System for Neonates / Pediatrics, 5 F, Y-Adapter by Avanos Medical Inc
Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
- 01.15
Urgent Field Safety Notice for Rusch GreenLite MAC (diverse Größen) by Teleflex Medical Athlone
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
- 01.13
Urgent Field Safety Notice for 1.5T SIGNA HDxt, SIGNA Architect, SIGNA Pioneer, SIGNA Premier by GE Medical Systems, LLC
Electromedical fields – equipment for MR tomography
- 01.13
Urgent Field Safety Notice for Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max by Siemens Healthcare GmbH, X-Ray Products (XP)
Radiological technology – stationary radiological equipment
- 01.13
Urgent Field Safety Notice for Epicite hydro by JeNaCell GmbH
Dressings / Pads – dressings
- 01.13
Urgent Field Safety Notice for BARD Site~Rite 8 Ultrasound System by Bard Access Systems Division (BASD)
Ultrasonics – ultrasonic diagnostic equipment
- 01.13
Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
- 01.09
Urgent Field Safety Notice for PowerMAG (in USA als Systembildung mit IT Komponenten: Apollo) by MAG & More GmbH
Electromedical fields – equipment for magnet therapy
- 01.09
Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH
Radiological technology – stationary radiological equipment
- 01.09
Urgent Field Safety Notice for Sterilizable handle “Hanaulux” by MAQUET SAS
Surgical equipment/ Anaesthesia – surgical equipment
- 01.09
Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH
Radiological technology – stationary radiological equipment
- 01.09
Urgent Field Safety Notice for Insufflationsschlauchset, mit Gasfilter by Karl Storz S. & Co KG
Optics / Precision engineering – endoscopes
- 01.21
Urgent Field Safety Notice for FTD Respiratory pathogens 21 by Fast-Track Diagnostics S.a.r.l.
In-vitro diagnostics – microbiological products
- 01.20
Urgent Field Safety Notice for cobas t511/t711 + Cuvette COBAS INTEGRA by Roche Diagnostics GmbH
In-vitro diagnostics – haematological, histological and cytological products
- 01.20
Urgent Field Safety Notice for UniCel DxH Slidemaker Stainer (SMS) by Beckman Coulter, Inc.
In-vitro diagnostics – haematological, histological and cytological products
- 01.20
Urgent Field Safety Notice for MRX PT Owren’s by MediRox AB
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.20
Urgent Field Safety Notice for ADVIA Centaur NT-proBNP and Atellica IM NT-proBNP; (N-terminal pro-brain natriuretic peptide) by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.20
Urgent Field Safety Notice for 8180 Gram-Positive Blood Culture Control Panel by Microbiologics
In-vitro diagnostics – microbiological products
- 01.20
Urgent Field Safety Notice for ADVIA Chemistry Lipase Reagent by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.20
Urgent Field Safety Notice for Getinge 88-series by Getinge Disinfection AB
General equipment for medical treatment – cleaning / disinfection / sterilisation
- 01.20
Urgent Field Safety Notice for Diverse modules by Hitachi High Technologies Corporation (HHT), Medical Systems QA Group
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.17
Urgent Field Safety Notice for Accu-Chek Solo pump base by Roche Diabetes Care GmbH
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 01.17
Urgent Field Safety Notice for different Certain BellaTek Encode Healing Abutments by Biomet 3i
Dental products – dental implants
- 01.16
Urgent Field Safety Notice for Affinis Inverse Glenosphäre 39 mit Fixationsschraube by Mathys AG Bettlach
Non-active implants – bone surgery
- 01.16
Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc.
Radiological technology – navigation systems
- 01.16
Urgent Field Safety Notice for ARTIS T PL E by Cristalens Industrie
Non-active implants – special implants
- 01.15
Urgent Field Safety Notice for RotaFlow Drive by Maquet Cardiopulmonary GmbH
Surgical equipment/ Anaesthesia – surgical equipment
- 01.22
Urgent Field Safety Notice for Procedure Trays containing Insufflation Tubing Set with Gas Filter by ArcRoyal Ltd.
Optics / Precision engineering – endoscopes
- 01.22
Urgent Field Safety Notice for ORBIS Medication by Agfa HealthCare N.V.
Medical data processing (software) – others
- 01.22
Urgent Field Safety Notice for NObreath V2 by Bedfont Scientific Limited
Medical electronics / Electromedical devices – pulmonary function diagnostics
- 01.21
Urgent Field Safety Notice for VITROS Chemistry Products Cl- & K++ Slides by Ortho Clinical Diagnostics Inc
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.21
Urgent Field Safety Notice for IMMULITE 2000/IMMULITE 2000 XPi EBV-VCA IgM by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – microbiological products
- 01.21
Urgent Field Safety Notice for Medonic M-Series/M32 Autoloader with Automatic Barcode Reader; Swelab Alfa/ Alfa Plus Sampler instruments with Automatic Barcode Reader by Boule Medical AB (Spånga)
In-vitro diagnostics – haematological, histological and cytological products
- 01.21
Urgent Field Safety Notice for Atellica IM 1300 and IM 1600 Analyzers by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.21
Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – radiological equipment for vascular diagnostics
- 01.21
Urgent Field Safety Notice for SINGLE USE MONOPOLAR CABLE by PETERS SURGICAL
Medical electronics / Electromedical devices – electrotherapy
- 01.21
Urgent Field Safety Notice for Autocon by Karl Storz S. & Co KG
Medical electronics / Electromedical devices – electrotherapy
- 01.21
Urgent Field Safety Notice for RIDA QUICK Malaria Control by R-Biopharm AG
In-vitro diagnostics – microbiological products
- 01.21
Urgent Field Safety Notice for Oxoid Streptococcal Selective Agar C.O.B.A by Thermo Fisher Scientific (Lenexa)
In-vitro diagnostics – microbiological products
- 01.21
Urgent Field Safety Notice for Efficia DFM100 by Philips Goldway (Shenzhen) Industrial Inc.
Medical electronics / Electromedical devices – electrotherapy
- 01.21
Urgent Field Safety Notice for MonojectT Syringe with Hypodermic Safety Needle, Hypodermic Safety Needle, Bluntfill with Filter by Covidien llc
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
- 01.21
Urgent Field Safety Notice for Enzymatic Creatinine Rgt, Advia, Atellica, Dimension (Vista) by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.31
Urgent Field Safety Notice for Olympus Evis Exera Pleura Videoscope LTF-160 by Olympus Corporation
Optics / Precision engineering – endoscopes
- 01.31
Urgent Field Safety Notice for Pilling CLEAR ADVANTAGE Disposable Aortic Punch by Teleflex Medical USA
Medical instruments for use in humans – vascular surgery
- 01.31
Urgent Field Safety Notice for Giraffe Blue Spot PT Lite by Datex-Ohmeda, Inc
Physical therapy – phototherapy
- 01.30
Urgent Field Safety Notice for WOmed by Wolf-Medizintechnik GmbH
Radiotherapy / Radiation protection – radiotherapeutic equipment
- 01.29
Urgent Field Safety Notice for CapsoCam Plus (SV-3) by CapsoVision, Inc
Optics / Precision engineering – endoscopes
- 01.29
Urgent Field Safety Notice for Deconex by Borer Chemie AG
General equipment for medical treatment – cleaning / disinfection / sterilisation
- 01.28
Urgent Field Safety Notice for ApexPro Telemetry System, CIC Pro Clinical Information Center Central Station and CARESCAPE Central Station by GE Medical Systems Information Technologies, Inc.
Medical electronics / Electromedical devices – electrodiagnostics
- 01.28
Urgent Field Safety Notice for Calcar Trimmer Shaft by Biomet UK Ltd
Medical instruments for use in humans – bone surgery
- 01.28
Urgent Field Safety Notice for NC Trek RX and NC Traveler RX by Abbott Vascular, Santa Clara
Injections / Infusions / Transfusions / Dialysis – catheters
- 01.28
Urgent Field Safety Notice for King Vision Video Adapter Size 1/2 by Ambu – King Systems
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
- 01.28
Urgent Field Safety Notice for Ellipse ICDs by Abbott CRM
Active implantable medical devices – defibrillators
- 01.28
Urgent Field Safety Notice for C-Section Tray and Sectio Set by Mölnlycke Health Care AB
Dressings / Pads – others
- 01.23
Urgent Field Safety Notice for OmniDiagnost Eleva MultiDiagnost Eleva with Flat D by Philips Medical Systems Nederland B.V
Radiological technology – stationary radiological equipment
- 01.23
Urgent Field Safety Notice for SPY-PHI Drape by Stryker Endoscopy-San Jose
Surgical equipment/ Anaesthesia – surgical equipment
- 01.22
Urgent Field Safety Notice for Mindray patient monitors by SHENZSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Medical electronics / Electromedical devices – electrodiagnostics
- 02.07
Urgent Field Safety Notice for Ysio by Siemens Healthcare GmbH, X-Ray Products (XP)
Radiological technology – stationary radiological equipment
- 02.07
Urgent Field Safety Notice for Stealth, Surgical Spring Clip by Applied Medical Resources
Medical instruments for use in humans – vascular surgery
- 02.06
Urgent Field Safety Notice for Optime, GXPS-500, Express, Scan eXam by PaloDEx Group Oy
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
- 02.06
Urgent Field Safety Notice for Surgical Clipper Charger by Medline Industries Inc.
Surgical equipment/ Anaesthesia – surgical equipment
- 02.05
Urgent Field Safety Notice for Selenia Dimensions by Hologic, Inc Marlborough
Radiological technology – radiological equipment for mammographic diagnostics
- 02.05
Urgent Field Safety Notice for INNOTERE Paste-CPC, VELOX, Calcifix by InnoTERE GmbH
Non-active implants – materials for implants
- 02.05
Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy
Non-active implants – special implants
- 02.05
Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.o
Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures
- 02.05
Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd.
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 02.04
Urgent Field Safety Notice for Telescopic Smoke Evacuation Pencil by LiNA Medical ApS
Medical electronics / Electromedical devices – electrotherapy
- 02.03
Urgent Field Safety Notice for Breelib Starter Pack, Breelib Monthly Pack by Vectura Group plc
Physical therapy – inhalation therapy
- 01.31
Urgent Field Safety Notice for CONTACT AIR spheric by Wöhlk-Contact-Linsen GmbH
ophthalmological technology – contact lenses
- 01.31
Urgent Field Safety Notice for Maestro Cardiac Ablation System by Boston Scientific Corporation Marlborough
Medical electronics / Electromedical devices – electrotherapy
- 01.31
Urgent Field Safety Notice for Cybex Eagle Incline Press 11150 by Life Fitness
Physical therapy – massage / mobility devices
- 01.31
Urgent Field Safety Notice for Powerheart G3 Elite AED by Cardiac Science Corp.
Medical electronics / Electromedical devices – electrotherapy
- 02.14
Urgent Field Safety Notice for Alaris Extension Sets, Low Sorbing (PE) by Shanghai Kindly Enterprise Development Group Co Ltd
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 02.13
Urgent Field Safety Notice for various FTD products by Fast-Track Diagnostics S.a.r.l.
In-vitro diagnostics – instruments, apparatuses and systems
- 02.13
Urgent Field Safety Notice for Elecsys Troponin T hs by Roche Diagnostics GmbH
In-vitro diagnostics – immunological products
- 02.13
Urgent Field Safety Notice for NycoCard D-Dimer by Abbott Diagnostics Technologies AS
In-vitro diagnostics – haematological, histological and cytological products
- 02.12
Urgent Field Safety Notice for PALAMIX UNO; PALAMIX DUO by Heraeus Medical GmbH
Surgical equipment/ Anaesthesia – surgical equipment
- 02.12
Urgent Field Safety Notice for PSPIX by SOPRO
Radiological technology – radiological equipment for stomatological diagnostics
- 02.12
Urgent Field Safety Notice for aura6000® Remote Control and Charger; 500.0100 / NA by LivaNova, Inc
Active implantable medical devices – biostimulators
- 02.12
Urgent Field Safety Notice for aura6000® Remote Control and Charger; 500.0100 / NA by LivaNova, Inc
Active implantable medical devices – biostimulators
- 02.11
Urgent Field Safety Notice for Mopyc – Stem; Radial Head Prosthesis by TORNIER SAS
Non-active implants – bone surgery
- 02.11
Urgent Field Safety Notice for Imager II Angiographic Catheter by Boston Scientific Corporation Natick
Injections / Infusions / Transfusions / Dialysis – catheters
- 02.11
Urgent Field Safety Notice for Arrow EPIDURAL CATHETERIZATION Kits and Sets by Teleflex Medical USA
Injections / Infusions / Transfusions / Dialysis – injection kits
- 02.10
Urgent Field Safety Notice for Oxylog VE300 by Drägerwerk AG & Co. KGaA
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 02.10
Urgent Field Safety Notice for Cutisoft Cotton XR 10cm x 10cm dressing gauze by BSN medical GmbH
Dressings / Pads – swabs, sponges, wipes, swabsticks
- 02.10
Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.
Radiological technology – stationary radiological equipment
- 02.10
Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc.
Medical electronics / Electromedical devices – electrotherapy
- 02.19
Urgent Field Safety Notice for Innex by Zimmer GmbH
Non-active implants – bone surgery
- 02.18
Urgent Field Safety Notice for MAGEC Spinal Bracing and Distraction System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc.
Active implantable medical devices – others
- 02.18
Urgent Field Safety Notice for ThermaCare by Pfizer Consumer Health Care
Physical therapy – climatotherapy
- 02.18
Urgent Field Safety Notice for Artis zeego & Artis zee/Q./Q.zen by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – radiological equipment for vascular diagnostics
- 02.18
Urgent Field Safety Notice for TA IQ FWD by Reha-Med Hilfsmittel GmbH
Orthopaedic / Rehabilitation technology – mobility aids
- 02.17
Urgent Field Safety Notice for Bellco MICROPLAS plasmafilters by Bellco S.p.A.
Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures
- 02.17
Urgent Field Safety Notice for TriVerse electrosurgical device by Covidien llc
Medical electronics / Electromedical devices – electrotherapy
- 02.14
Urgent Field Safety Notice for MyCare Insite Clozapine Test Kit by Saladax Biomedical, Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.14
Urgent Field Safety Notice for Rotor-Gene Q by QIAGEN GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.14
Urgent Field Safety Notice for Chemistry QC Premium Plus by Randox Laboratories Ltd
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.14
Urgent Field Safety Notice for MyCare Insite Clozapine Test Kit by Saladax Biomedical, Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.14
Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC
In-vitro diagnostics – microbiological products
- 02.14
Urgent Field Safety Notice for NucliSENS Lysis Buffer by bioMérieux S. (Marcy- l’Etoile)
In-vitro diagnostics – microbiological products
- 02.14
Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by Siemens Medical Solutions Diagnostics
In-vitro diagnostics – immunological products
- 02.14
Urgent Field Safety Notice for Hemochron Signature Elite by Accriva Diagnostics, Inc. dba as International Technidyne Corp.
In-vitro diagnostics – haematological, histological and cytological products
- 02.28
Urgent Field Safety Notice for elisa 300, elisa 500, elisa 600, elisa 800 und elisa 800VIT by Löwenstein Medical Innovation GmbH & Co. KG
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 02.28
Urgent Field Safety Notice for eCLIPs Bifurcation Remodelling System by Evasc Medical Systems Corp.
Non-active implants – special implants
- 02.28
Urgent Field Safety Notice for ARTISTE MV Systems; ONCOR; PRIMUS; MEVATRON by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
- 02.27
Urgent Field Safety Notice for X-Change by Howmedica Osteonics Corporation
Medical instruments for use in humans – bone surgery
- 02.27
Urgent Field Safety Notice for Niederdruckschlauch, CO2, 150 cm by Karl Storz S. & Co KG
Physical therapy – insufflation technique
- 02.27
Urgent Field Safety Notice for Monopolare Schere IN CUT; Monopolare Pinzette ENDOGRIP; Monopolare Haken ENDOHOOK by PETERS SURGICAL
Medical electronics / Electromedical devices – electrotherapy
- 02.27
Urgent Field Safety Notice for MR-Set ELS 65ml , ELS 65ml syringe by MEDTRON AG
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 02.21
Urgent Field Safety Notice for SMR Shoulder cementless finned stem L.80mm dia.19m by Lima Corporate S.p.A.
Non-active implants – bone surgery
- 02.21
Urgent Field Safety Notice for ETHIBOND EXCEL Polyester Suture by Ethicon, Inc.
Dressings / Pads – surgical sutures, vascular loops etc.
- 02.21
Urgent Field Safety Notice for Nextra Hammertoe Correction System by Nextremity Solutions, Inc.
Non-active implants – bone surgery
- 02.20
Urgent Field Safety Notice for Raymat AS1 by Raymed Imaging AG
Radiological technology – stationary radiological equipment
- 02.19
Urgent Field Safety Notice for COROFLEX ISAR NEO 2.25 X 24 MM by B. Braun Melsungen AG, Aesculap Division Vascular Systems
Non-active implants – special implants
- 02.19
Urgent Field Safety Notice for CYTOGUIDE needle guide bushes by Turon MedTech AB
Medical instruments for use in humans – general instruments
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