Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.05.2020 – 30.06.2020

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• 05.05

Urgent Field Safety Notice for T2 Locking Screws, Compression Screws, End Caps, Gamma3 End Caps by Stryker Trauma GmbH

Non-active implants – bone surgery

PDF43KB

• 05.05

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF224KB

• 05.05

Urgent Field Safety Notice for TraumaDiagnost by Philips Medical Systems DMC GmbH

Radiological technology – stationary radiological equipment

PDF835KB

• 05.05

Urgent Field Safety Notice for Cardia Ultraseal Left Atrial Appendage Closure Device by Cardia Incorp.

Non-active implants – cardiac surgery

PDF136KB

• 05.04

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

Radiological technology – radiological equipment for vascular diagnostics

PDF623KB

• 05.04

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

Radiological technology – radiological equipment for vascular diagnostics

PDF211KB

• 05.04

Urgent Field Safety Notice for Aleutian AN (Anatomically Narrow) Lordotic Spread by Stryker Spine – Leesburg

Medical instruments for use in humans – bone surgery

PDF172KB

• 05.13

Urgent Field Safety Notice for EV1000 Clinical Platform System by Edwards Lifesciences LLC

Medical electronics / Electromedical devices – electrodiagnostics

PDF1,011KB

• 05.11

Urgent Field Safety Notice for Zenition 50, Zenition 70 Systems by Philips Medical Systems Nederland B.V

Radiological technology – mobile radiological diagnostic facilities

PDF1MB

• 05.11

Urgent Field Safety Notice for TruSystem 7500 by TRUMPF Medizin Systeme GmbH + Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF474KB

• 05.11

Urgent Field Safety Notice for HeartStart XL by Philips Medical Systems

Medical electronics / Electromedical devices – electrotherapy

PDF544KB

• 05.11

Urgent Field Safety Notice for R3 Acetabular Shell by Smith & Nephew, Inc.,

Non-active implants – bone surgery

PDF104KB

• 05.08

Urgent Field Safety Notice for V60 Ventilator by Respironics California, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF521KB

• 05.08

Urgent Field Safety Notice for Epiguide by Episurf Operations AB

Medical instruments for use in humans – bone surgery

PDF4MB

• 05.08

Urgent Field Safety Notice for Epidummy by Episurf Operations AB

Medical instruments for use in humans – bone surgery

PDF4MB

• 05.07

Urgent Field Safety Notice for Pneumograph, chest, NM, 3160 _ 94023 by Philips Medical Systems

Electromedical fields – equipment for MR tomography

PDF5MB

• 05.07

Urgent Field Safety Notice for ARCHITECT iGentamicin Reagent Kit by Abbott GmbH & Co.KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF111KB

• 05.06

Urgent Field Safety Notice for Giraffe Shuttle by Datex-Ohmeda, Inc

Physical therapy – climatotherapy

PDF257KB

• 05.06

Urgent Field Safety Notice for TruLab Protein Level 1 by DiaSys Diagnostic Systems GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

• 05.06

Urgent Field Safety Notice for Fully Automated Urine Particle Analyzer UF-4000 / Fully Automated Urine Particle Analyzer UF-5000 by Sysmex Corporation

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

• 05.06

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

Radiological technology – radiological equipment for mammographic diagnostics

PDF382KB

• 05.05

Urgent Field Safety Notice for Insulinpumpe DANA Diabecare RS;mobilen Anwendung AnyDANA by SOOIL Development Co. Ltd.

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF363KB

• 05.26

Urgent Field Safety Notice for PlastiSept eco by Alpro Dental-Produkte GmbH

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF1MB

• 05.26

Urgent Field Safety Notice for TiMAX 6.5mm/8.0mm Large Cannulated Screw System by Biomet Orthopedics, LLC

Medical instruments for use in humans – bone surgery

PDF429KB

• 05.26

Urgent Field Safety Notice for Adapter Optiloc for handpiece, length 26mm by Valoc AG

Medical instruments for use in humans – bone surgery

PDF3MB

• 05.26

Urgent Field Safety Notice for ABL90 FLEX and ABL90 PLUS by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF33KB

• 05.20

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF95KB

• 05.20

Urgent Field Safety Notice for FluoroType CDiff VER 1.0 by Hain Lifescience GmbH

In-vitro diagnostics – microbiological products

PDF1MB

• 05.20

Urgent Field Safety Notice for Giraffe Omnibed, Giraffe Incubator by Datex-Ohmeda, Inc

Physical therapy – climatotherapy

PDF367KB

• 05.19

Urgent Field Safety Notice for Comprehensive by Biomet Orthopedics, LLC

Medical instruments for use in humans – bone surgery

PDF391KB

• 05.18

Urgent Field Safety Notice for Impactor Handle by Waldemar Link GmbH & Co. KG

Medical instruments for use in humans – bone surgery

PDF6MB

• 05.15

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

PDF449KB

• 05.14

Urgent Field Safety Notice for Internal Sterilizable Defibrillator paddles by Philips Medical Systems

Medical electronics / Electromedical devices – electrotherapy

PDF175KB

• 05.13

Urgent Field Safety Notice for Niobe ES by Stereotaxis, Inc

Radiological technology – navigation systems

PDF84KB

• 05.13

Urgent Field Safety Notice for xevonta Lo 18, xevonta Hi 18, xevonta Hi 20 by B. Braun Avitum AG

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF23KB

• 05.13

Urgent Field Safety Notice for RüschCare TracFlex Plus Tracheostomy Tube with Subglottic Suction Set, Cuffed by Teleflex Medical Athlone

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF183KB

• 05.13

Urgent Field Safety Notice for EVOSET AFB K+ INFUSION, CARTRIDGE WITH HEMOSCAN, AR by Gambro Dasco S.p.A.

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF119KB

• 05.28

Urgent Field Safety Notice for Alinity C Processing Module by Abbott GmbH & Co. KG

In-vitro diagnostics – equipment / products for clinical chemistry

PDF118KB

• 05.28

Urgent Field Safety Notice for EliA Stool Extraction Kit by Phadia AB

In-vitro diagnostics – immunological products

PDF94KB

• 05.28

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

PDF191KB

• 05.28

Urgent Field Safety Notice for PentaRay NAV Catheter by Biosense Webster, Inc. (Diamond Bar)

Injections / Infusions / Transfusions / Dialysis – catheters

PDF148KB

• 05.27

Urgent Field Safety Notice for recomWell Helicobacter IgA by Mikrogen GmbH

In-vitro diagnostics – microbiological products

PDF351KB

• 05.27

Urgent Field Safety Notice for LEGIONELLA-M.W.Y.-SELEKTIVNÄHRBODEN by Oxoid Deutschland GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF148KB

• 05.27

Urgent Field Safety Notice for BD BBL Gram Crystal Violet 250mL & Grain Stain Kit by Becton, Dickinson and Company

In-vitro diagnostics – microbiological products

PDF32KB

• 05.27

Urgent Field Safety Notice for Bil. Auto Dir.;Bil. Auto Total; Cre. mod. Jaffe by DIALAB GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF68KB

• 05.27

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

In-vitro diagnostics – microbiological products

PDF181KB

• 05.27

Urgent Field Safety Notice for CentraLink(R) Data Management System and Atellica(R) Data Manager by Siemens Healthcare Diagnostics Inc.- Glasgow

Medical electronics / Electromedical devices – electrodiagnostics

PDF47KB

• 05.27

Urgent Field Safety Notice for ABL80 FLEX/CO-OX by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF34KB

• 05.27

Urgent Field Safety Notice for Mentype MycoDermQS Lateral Flow by Biotype Diagnostic GmbH

In-vitro diagnostics – microbiological products

PDF83KB

• 05.27

Urgent Field Safety Notice for Radiometer ABL800 FLEX by Radiometer Medical ApS

In-vitro diagnostics – equipment / products for clinical chemistry

PDF22KB

• 05.27

Urgent Field Safety Notice for Alere NT-proBNP Control/Alere NT-proBNP Calibrator by Axis-Shield Diagnostics Limited

In-vitro diagnostics – immunological products

PDF84KB

• 05.27

Urgent Field Safety Notice for Automated Enzyme Immunoassay Analyzer AIA-360 by Tosoh Corporation

In-vitro diagnostics – equipment / products for clinical chemistry

PDF4MB

• 06.05

Urgent Field Safety Notice for SWISS optio jetflow by Gebr. Gloor AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF5MB

• 06.05

Urgent Field Safety Notice for SWISS optio jetflow by Gebr. Gloor AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF5MB

• 06.04

Urgent Field Safety Notice for G4 Platinum and G5 Mobile receiver by Dexcom, Inc

Medical electronics / Electromedical devices – electric blood glucose meters

PDF66KB

• 06.03

Urgent Field Safety Notice for optimys Rasp Handle double offset left by Mathys AG Bettlach

Medical instruments for use in humans – bone surgery

PDF159KB

• 06.02

Urgent Field Safety Notice for TactiCathTM Quartz Contact Force Ablation Catheter by Abbott Plymouth, Product Performance Group

Injections / Infusions / Transfusions / Dialysis – catheters

PDF154KB

• 06.02

Urgent Field Safety Notice for TruSystem 3000 by TRUMPF Medizin Systeme GmbH + Co. KG

Surgical equipment/ Anaesthesia – surgical equipment

PDF413KB

• 06.02

Urgent Field Safety Notice for Bedside to Patient Unit Cable (PURU3) by Natus Medical Incorporated – Ontario

Medical electronics / Electromedical devices – electrodiagnostics

PDF131KB

• 06.02

Urgent Field Safety Notice for FreeStyle LibreLink App by Abbott Diabetes Care Ltd. UK

Medical data processing (software) – facet_09md-07

PDF149KB

• 06.02

Urgent Field Safety Notice for FreeStyle Libre 2 by Abbott Diabetes Care Ltd. UK

Medical electronics / Electromedical devices – electric blood glucose meters

PDF108KB

• 06.02

Urgent Field Safety Notice for ThermoShield Neonatal HME by Flexicare Medical Limited

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF366KB

• 06.02

Urgent Field Safety Notice for Restoration Anatomic Shell by Howmedica Osteonics Corporation

Non-active implants – bone surgery

PDF495KB

• 05.28

Urgent Field Safety Notice for SPIF by BALT Extrusion

Non-active implants – special implants

PDF316KB

• 05.28

Urgent Field Safety Notice for VITROS Chemistry Product AMYL Slides Reagent by Ortho Clinical Diagnostics Inc

In-vitro diagnostics – equipment / products for clinical chemistry

PDF423KB

• 05.28

Urgent Field Safety Notice for Dimension, Dimension Vista, Atellica CH, ADVIA Chemistry Fructosamine, Enzymatic Creatinine, Cholesterol, Creatinine, Direct HDL, Direct LDL, Glucose Oxidase, Lactate by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

PDF830KB

• 05.28

Urgent Field Safety Notice for Remisol Advance v.1.12 by NORMAND INFO

In-vitro diagnostics – equipment / products for clinical chemistry

PDF37KB

• 06.18

Urgent Field Safety Notice for Zenith Alpha Abdominal Endovascular Graft – ZIMB ZLC ZLBE ZISL by William Cook Europe ApS

Non-active implants – special implants

PDF5MB

• 06.17

Urgent Field Safety Notice for Liver Assist, Kidney Assist, Lung Assist by Organ Assist

Surgical equipment/ Anaesthesia – surgical equipment

PDF226KB

• 06.17

Urgent Field Safety Notice for Passeo-18 Lux by BIOTRONIK AG

Injections / Infusions / Transfusions / Dialysis – catheters

PDF97KB

• 06.17

Urgent Field Safety Notice for DeBakey Nadelhalter 23 cm by Dufner Instrumente GmbH

Medical instruments for use in humans – general instruments

PDF108KB

• 06.17

Urgent Field Safety Notice for Rusch TracFlex Plus Set, cuffed, TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed by Teleflex (Perak West Malaysia)

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF244KB

• 06.17

Urgent Field Safety Notice for IceFORCE & IcePearl 2.1 CX Cryoablation Needles by Galil Medical Ltd.

Surgical equipment/ Anaesthesia – surgical equipment

PDF929KB

• 06.15

Urgent Field Safety Notice for JiveX by VISUS Technology Transfer GmbH

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

PDF80KB

• 06.15

Urgent Field Safety Notice for JASPIS S. by Signus Medizintechnik GmbH

Non-active implants – bone surgery

PDF689KB

• 06.15

Urgent Field Safety Notice for IN.PACT Admiral and IN.PACT Pacific by Medtronic Inc

Injections / Infusions / Transfusions / Dialysis – catheters

PDF144KB

• 06.10

Urgent Field Safety Notice for Silicone Implant and Expanders by Groupe Sebbin SAS

Non-active implants – special implants

PDF254KB

• 06.10

Urgent Field Safety Notice for Silicone Implant and Expanders by Groupe Sebbin SAS

Non-active implants – special implants

PDF220KB

• 06.10

Urgent Field Safety Notice for Silicone gel-filled sizers by Groupe Sebbin SAS

Non-active implants – special implants

PDF216KB

• 06.10

Urgent Field Safety Notice for TEM-SCHLAUCHSET by Richard Wolf GmbH

Optics / Precision engineering – endoscopes

PDF116KB

• 06.08

Urgent Field Safety Notice for Carescape Patient Data Module by GE Medical Systems Information Technologies, Inc.

Medical electronics / Electromedical devices – electrodiagnostics

PDF213KB

• 06.05

Urgent Field Safety Notice for CareLink Programmer; CareLink Encore Programmer by Medtronic Inc

Active implantable medical devices – defibrillators

PDF51KB

• 06.23

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF61KB

• 06.19

Urgent Field Safety Notice for MERLIN PROGRAMMER by S.. Jude Medical CRMD

Active implantable medical devices – defibrillators

PDF47KB

• 06.18

Urgent Field Safety Notice for LoFric Origo by Wellspect HealthCare

Injections / Infusions / Transfusions / Dialysis – catheters

PDF183KB

• 06.18

Urgent Field Safety Notice for iVascular LUMINOR by iVascular S.L.U.

Injections / Infusions / Transfusions / Dialysis – catheters

PDF132KB

• 06.18

Urgent Field Safety Notice for Zilver PTX Drug-Eluting Peripheral Stent by Cook Incorporated

Non-active implants – special implants

PDF99KB

• 06.18

Urgent Field Safety Notice for BioPath 014 & BioPath 035 by BIOSENSORS Europe SA

Injections / Infusions / Transfusions / Dialysis – catheters

PDF137KB

• 06.18

Urgent Field Safety Notice for SeQuent Please OTW by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis – catheters

PDF119KB

• 06.18

Urgent Field Safety Notice for Arrow FlexTip Plus(R) Epidural Kit with NRFit(R) connector by Teleflex Medical USA

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF180KB

• 06.18

Urgent Field Safety Notice for ELUVIA Drug-Eluting Vascular Stent System by Boston Scientific Corporation Marlborough

Non-active implants – special implants

PDF146KB

• 06.18

Urgent Field Safety Notice for Stellarex OTW Drug-coated Angioplasty Balloon by Spectranetics

Injections / Infusions / Transfusions / Dialysis – catheters

PDF443KB

• 06.18

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

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF2MB

• 06.18

Urgent Field Safety Notice for Ranger by Hemoteq AG

Injections / Infusions / Transfusions / Dialysis – catheters

PDF146KB

• 06.18

Urgent Field Safety Notice for Integrated Power Consoles (IPCs) by Medtronic Xomed Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF69KB

• 06.18

Urgent Field Safety Notice for Rely+On Perasafe by Antec International Limited

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF91KB

• 06.18

Urgent Field Safety Notice for Lokomat by Hocoma AG

Medical electronics / Electromedical devices – functional diagnostics by way of gas exchange and exercise

• 06.29

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

Radiological technology – CT scanners

PDF275KB

• 06.29

Urgent Field Safety Notice for HYGENIC Dental Dam Forceps by Coltene/Whaledent, lnc.

Dental products – instruments

PDF104KB

• 06.29

Urgent Field Safety Notice for BARD SafeStep Huber Needle Sets by Bard Access Systems Division (BASD)

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF190KB

• 06.29

Urgent Field Safety Notice for ACTIV.A.C. Therapy System by KCI International, Inc.

Surgical equipment/ Anaesthesia – surgical equipment

PDF205KB

• 06.26

Urgent Field Safety Notice for Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser surgery by Teleflex Medical Athlone

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF153KB

• 06.26

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

Medical electronics / Electromedical devices – electrotherapy

PDF217KB

• 06.25

Urgent Field Safety Notice for Integra MicroFrance Bipolar Electrosurgical by Integra MicroFrance SAS

Medical electronics / Electromedical devices – electrotherapy

PDF181KB

• 06.25

Urgent Field Safety Notice for SELDICATH PU EXTENSION, SELDICATH FEP, SELDICATH PTFE, MICRODARD, DISP BLOC PARA-CERVICAL DEPASST, PLEUROCATH NEONATAL, PLEUROCATH PEDIATRIE, PLEUROCATH ADULTES, PLEUROCATH SAMU, PLEUROCATH SELDINGER, PLEUROCATH GUIBOUT, COMBICATH by PRODIMED

Injections / Infusions / Transfusions / Dialysis – drainages and suction systems

PDF482KB

• 06.25

Urgent Field Safety Notice for 3M Transbond Plus Light Cure Band Adhesive Kit by 3M Unitek Corporation

Dental products – orthodontic equipment

PDF24KB

• 06.25

Urgent Field Safety Notice for ETHICON PERMA-HAND (or MERSILK) Silk Suture by Ethicon Products

Dressings / Pads – surgical sutures, vascular loops etc.

PDF285KB

• 06.25

Urgent Field Safety Notice for Diverse Lutonix Drug Coated Balloon PTA Catheter by Lutonix, Inc

Injections / Infusions / Transfusions / Dialysis – catheters

PDF98KB

• 06.23

Urgent Field Safety Notice for Flexitron HDR – Flexitron Cobalt-60 by Elekta Global Post Market Surveillance Department

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF63KB

• 06.23

Urgent Field Safety Notice for SmartSync Gerätemanager für AzureT Schrittmacher und PerceptaT, SerenaT, SolaraT CRT-Schrittmacher by Medtronic Inc

Active implantable medical devices – defibrillators

PDF53KB

• 06.23

Urgent Field Safety Notice for Comprehensive by Biomet Orthopedics, LLC

Medical instruments for use in humans – bone surgery

PDF402KB

• 06.23

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF276KB

• 06.30

Urgent Field Safety Notice for SUTUREFIX ULTRA 1.7MM DRILL (S) by Smith & Nephew, Inc., Endoscopy Division

Medical instruments for use in humans – bone surgery

PDF49KB

• 06.30

Urgent Field Safety Notice for T-FIX RCG Sterile Drill by Smith & Nephew, Inc., Endoscopy Division

Medical instruments for use in humans – bone surgery

PDF68KB