Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2019 – 31.03.2019

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Urgent Field Safety Notice for Mayfield Skull Clamp by IntegraLifeSciences Mayfield

Surgical equipment/ Anaesthesia - surgical equipment

PDF2MB

Urgent Field Safety Notice for Navina rectal catheter regular + associated device by Wellspect HealthCare

Physical therapy - hydrotherapy

PDF125KB

Urgent Field Safety Notice for CW002, 5x42CM EPIX ES PRB SMK EVAC LHOOK by Applied Medical Resources Corporation

Optics / Precision engineering - endoscopes

PDF519KB

Urgent Field Safety Notice for Octenidol md Mundspüllösung by MPC International S.A.

Dental products - others

PDF140KB

Urgent Field Safety Notice for Eye Station by Merge Healthcare

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

PDF55KB

Urgent Field Safety Notice for IMTEC-b2-Glycoprotein I-Antibodies IgG by HUMAN Gesellschaft für Biochemica und Diagnostica mbH

In-vitro diagnostics - immunological products

PDF89KB

Urgent Field Safety Notice for Flexima Duodenal Bend Biliary Stent with Delivery by Boston Scientific Corporation Marlborough

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

PDF171KB

Urgent Field Safety Notice for Celsite Safety by B.BRAUN MEDICAL Saint Cloud

Non-active implants - special implants

PDF30KB

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

In-vitro diagnostics - equipment / products for clinical chemistry

PDF128KB

Urgent Field Safety Notice for JOURNEY DCF AP Femoral Cutting Block Size 3 by Smith & Nephew, Inc.,

Medical instruments for use in humans - bone surgery

PDF145KB

Urgent Field Safety Notice for ALLOFIT ALLO-C SCR PLUG STER by Zimmer GmbH

Non-active implants - bone surgery

PDF268KB

Urgent Field Safety Notice for Entuit Secure Gastrointestinal Suture Anchor Set by Cook Incorporated

Non-active implants - special implants

PDF101KB

Urgent Field Safety Notice for HS Curing light by Henry Schein Inc.

Dental products - equipment

PDF9KB

Urgent Field Safety Notice for Interactive Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC.

Dental products - dental implants

PDF201KB

Urgent Field Safety Notice for Vertex Orthoplast by Vertex-Dental B.V.

Dental products - dental material

PDF3MB

Urgent Field Safety Notice for Volcano s5i, CORE und CORE Mobile by Volcano Corporation San Diego

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

PDF1MB

Urgent Field Safety Notice for Efficia 3/5 ECG Trunk Cable, AAMI/IEC by Philips Medical Systems

Medical electronics / Electromedical devices - electrotherapy

PDF65KB

Urgent Field Safety Notice for Atellica IM Anti-Thyreoglobulin (aTG), ADVIA Centaur by Bayer HealthCare LLC jetzt Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics - immunological products

PDF2MB

Urgent Field Safety Notice for Mobi-C by LDR MEDICAL

Non-active implants - bone surgery

PDF445KB

Urgent Field Safety Notice for Baha 5 Sound Processor Tamper-proof battery door 3 by Cochlear Bone Anchored Salutions AB

Medical electronics / Electromedical devices - ENT equipment

PDF412KB

Urgent Field Safety Notice for Minstrel by ArjoHuntleigh AB

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

PDF355KB

Urgent Field Safety Notice for Max VPC Instrument Tray & Screw Caddy by Biomet Orthopedics, LLC

Medical instruments for use in humans - bone surgery

PDF499KB

Urgent Field Safety Notice for IONTRIS by Siemens Healthcare GmbH, Advanced Therapies, Particle Therapy

Radiotherapy / Radiation protection - nuclear medical therapeutic equipment

PDF87KB

Urgent Field Safety Notice for Fructosamine Calibrators and Controls by Randox Laboratories Ltd

In-vitro diagnostics - immunological products

PDF682KB

Urgent Field Safety Notice for Dimension Vista 500/1500 mit Progard Vorbehandlungspack by Siemens Healthcare Diagnostics Inc. Newark

In-vitro diagnostics - equipment / products for clinical chemistry

PDF100KB

Urgent Field Safety Notice for VITROS Chemistry Products VALP Slides by Ortho-Clinical Diagnostics, Inc.

In-vitro diagnostics - equipment / products for clinical chemistry

PDF367KB

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy

PDF52KB

Urgent Field Safety Notice for Various by Abbott Ireland Diagnostics Division

In-vitro diagnostics - immunological products

PDF183KB

Urgent Field Safety Notice for cobas t 511 and t 711 - Coagulation analyzer by Roche Diagnostics GmbH

In-vitro diagnostics - haematological, histological and cytological products

PDF480KB

Urgent Field Safety Notice for Quo-Test A1C Test Kit by EKF-diagnostic GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF3MB

Urgent Field Safety Notice for Eclipse Treatment Planning System by Varian Medical Systems, Inc.

Radiotherapy / Radiation protection - radiotherapy treatment planning systems

PDF638KB

Urgent Field Safety Notice for CLEAN by Roche Diagnostics GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF488KB

Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation

Active implantable medical devices - artificial hearts

PDF25KB

Urgent Field Safety Notice for BILT3,IGM-2, LACT2 und Lactate by Roche Diagnostics GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF171KB

Urgent Field Safety Notice for cobas 8100 system- see below in "Accessories" by Hitachi High Technologies Corporation (HHT), Medical Systems QA Group

In-vitro diagnostics - equipment / products for clinical chemistry

PDF544KB

Urgent Field Safety Notice for Architect B12 Reagenz by Abbott Ireland Diagnostics Division

In-vitro diagnostics - equipment / products for clinical chemistry

PDF210KB

Urgent Field Safety Notice for STACLOT LA by Stago

In-vitro diagnostics - haematological, histological and cytological products

PDF52KB

Urgent Field Safety Notice for Centricity Universal Viewer by GEHEALTHCARE INTEGRATED IT SOLUTIONS Inc

Medical data processing (software) - data processing facilities for image processing

PDF318KB

Urgent Field Safety Notice for ECLIPSE 2L by BALT Extrusion

Injections / Infusions / Transfusions / Dialysis - catheters

PDF312KB

Urgent Field Safety Notice for Leica M220 F12 by Leica Microsystems (Schweiz) AG

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

PDF1MB

Urgent Field Safety Notice for Percuvance 29cm Shaft Percuvance 36cm Shaft by Teleflex Medical USA

Optics / Precision engineering - endoscopes

PDF185KB

Urgent Field Safety Notice for Artikon.genu-bi-lock Systemkniegelenksatz mit Sperre, Systemschienenbreite 16 und 20 mm by Streifeneder ortho.production GmbH

Orthopaedic / Rehabilitation technology - orthoses

PDF354KB

Urgent Field Safety Notice for Reverse Loaded Wire Guides by Cook Incorporated

Injections / Infusions / Transfusions / Dialysis - catheters

PDF91KB

Urgent Field Safety Notice for Lambotte-Meißel, 20mm by aap Implantate AG

Medical instruments for use in humans - bone surgery

PDF4MB

Urgent Field Safety Notice for Vectris by Medtronic Inc

Active implantable medical devices - biostimulators

PDF73KB

Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare

Medical electronics / Electromedical devices - electrotherapy

PDF1,023KB

Urgent Field Safety Notice for Intera, Enterprise, Achieva, Achieva XT, Achieva C by Philips Medical Systems Nederland B.V.

Electromedical fields - equipment for MR tomography

PDF444KB

Urgent Field Safety Notice for Senographe Crystal Nova by GEULTRASOUND KOREA, LTD

Radiological technology - radiological equipment for mammographic diagnostics

PDF382KB

Urgent Field Safety Notice for Reprocessed Biosense Webster Lasso 2515 NAV eco Va by Stryker Sustainability Solutions

Injections / Infusions / Transfusions / Dialysis - catheters

PDF143KB

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

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF106KB

Urgent Field Safety Notice for smartPen, 2 Tasten, ø2,4mm, 4 by Gebrüder Martin GmbH & Co. KG

Medical electronics / Electromedical devices - electrotherapy

PDF226KB

Urgent Field Safety Notice for PLUS S. MIA DBL OFFSET ADAPT. RT 60/25MM by Smith & Nephew Orthopaedics AG

Medical instruments for use in humans - bone surgery

PDF115KB

Urgent Field Safety Notice for UNIMED Medical Needle by UNIMED S.A.

Injections / Infusions / Transfusions / Dialysis - injection kits

PDF59KB

Urgent Field Safety Notice for Instrument Tray, Basic T2 Femur Long by Stryker Trauma Kiel

Medical instruments for use in humans - bone surgery

PDF192KB

Urgent Field Safety Notice for Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series Implantable Pulse Generators (IPG) by Medtronic Inc

Active implantable medical devices - cardiac pacemakers

PDF84KB

Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd.

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF2MB

Urgent Field Safety Notice for Absaug-, S.ül- oder Drainageschlauch by Silikon-Technik Siltec GmbH & Co. KG

Optics / Precision engineering - endoscopes

PDF2MB

Urgent Field Safety Notice for Nellix (Version 3.5), Endovascular Aneurysm Sealing System by Endologix, Inc.

Non-active implants - other implants

PDF1MB

Urgent Field Safety Notice for Trima Accel System (Automated Blood Collection) by Terumo BCT, Inc

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

PDF92KB

Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah

Injections / Infusions / Transfusions / Dialysis - catheters

PDF661KB

Urgent Field Safety Notice for Efficia CM10, CM12, CM100, CM120, CM150 by Philips Medical Systems

Medical electronics / Electromedical devices - electrodiagnostics

PDF151KB

Urgent Field Safety Notice for Spectra Optia System by Terumo BCT, Inc

Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures

PDF75KB

Urgent Field Safety Notice for Ancora, Novaplus T and Gold T Normal by Eurogine S.L.

Contraception - intrauterine device

PDF3MB

Urgent Field Safety Notice for NIM-ECLIPSE System by Medtronic Xomed Inc.

Medical electronics / Electromedical devices - electrodiagnostics

PDF68KB

Urgent Field Safety Notice for Ziehm Vision RFD; Vision RFD 3D; Ziehm Solo FD by Ziehm Imaging GmbH

Radiological technology - mobile radiological diagnostic facilities

PDF26KB

Urgent Field Safety Notice for Burr, Oval, 12 Flute, 5.5 mm x 13 cmby Arthrex INC

Surgical equipment/ Anaesthesia - surgical equipment

PDF86KB

Urgent Field Safety Notice for Celsite Implantofix by B.BRAUN MEDICAL

Non-active implants - special implants

PDF30KB

Urgent Field Safety Notice for Ingenuity TF PET/CT by PHILIPS MEDICAL SYSTEMS (Cleveland), Inc. (CL)

Radiological technology - CT scanners

PDF3MB

Urgent Field Safety Notice for Oxoid BrillianceT ESBL/Brilliance CRE Bi-Plate by Thermo Fisher Scientific - Microbiology Central Reporting

In-vitro diagnostics - microbiological products

PDF248KB

Urgent Field Safety Notice for Software für Immunomate by Institut VirionSerion GmbH

In-vitro diagnostics - instruments, apparatuses and systems

PDF1MB

Urgent Field Safety Notice for Oxoid M.I.C.E Meropenem MA0121 by Thermo Fisher Scientific Microbiology Basingstoke

In-vitro diagnostics - microbiological products

PDF312KB

Urgent Field Safety Notice for TGS TA EBV Contra! Set by Technogenetics s.r.l.

In-vitro diagnostics - equipment / products for clinical chemistry

PDF1MB

Urgent Field Safety Notice for Breathing Circuits/Anesthesia Sets/Pack2Go/Set2Go by Drägerwerk AG & Co. KGaA

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF2MB

Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V.

Radiological technology - stationary radiological equipment

PDF121KB

Urgent Field Safety Notice for Philips Hemodynamic Application R1.0 by Philips Medical Systems Nederland B.V.

Medical electronics / Electromedical devices - electrodiagnostics

PDF242KB

Urgent Field Safety Notice for MAKO Vizadisc Knee/Hip Procedure Tracking Kit by MAKO Surgical Corp.

Surgical equipment/ Anaesthesia - surgical equipment

PDF152KB

Urgent Field Safety Notice for Fitbone TAA by Wittenstein intens GmbH

Active implantable medical devices - others

PDF70KB

Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems

Medical electronics / Electromedical devices - electrodiagnostics

PDF85KB

Urgent Field Safety Notice for Harmonic ACE Curved Shears Insert by Intuitive Surgical, Inc.

Surgical equipment/ Anaesthesia - surgical equipment

PDF613KB

Urgent Field Safety Notice for Agile Biliary RX Fully Covered Stent System by Boston Scientific Corporation Marlborough

Non-active implants - special implants

PDF162KB

Urgent Field Safety Notice for Suction Catheters, Gastro-enteral Tubes by ConvaTec Limited Deeside

Surgical equipment/ Anaesthesia - surgical equipment

PDF484KB

Urgent Field Safety Notice for Acusnare Polypectomy Snares by Cook Endoscopy

Optics / Precision engineering - endoscopes

PDF100KB

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

Active implantable medical devices - defibrillators

PDF279KB

Urgent Field Safety Notice for LOGIQ P6 systems by GE Medical Systems Information Technologies GmbH

Ultrasonics - ultrasonic diagnostic equipment

PDF280KB

Urgent Field Safety Notice for Padlock Clip defect closure system by United States Endoscopy Group, Inc.

Medical instruments for use in humans - general instruments

PDF8MB

Urgent Field Safety Notice for AXIUS Blower Mister by Maquet Cardiovascular

Optics / Precision engineering - endoscopes

PDF88KB

Urgent Field Safety Notice for Acuson NX2 , NX2 Elite, NX3, NX3 Elite, by Siemens Medical Solutions USA, Inc. Ultrasound

Ultrasonics - ultrasonic diagnostic equipment

PDF552KB

Urgent Field Safety Notice for Broach handles for rasp used in orthopedic surgery for the implantation of by EVOLUTIS SAS

Medical instruments for use in humans - bone surgery

PDF162KB

Urgent Field Safety Notice for Celsite Safety by B.BRAUN MEDICAL Saint Cloud

Non-active implants - special implants

PDF29KB

Urgent Field Safety Notice for Cortical Screw 3.5 by aap Implantate AG

Non-active implants - bone surgery

PDF59KB

Urgent Field Safety Notice for Immunoassay-Systeme UniCel DxI 600 und 800 Access by Beckman Coulter, Inc.

In-vitro diagnostics - equipment / products for clinical chemistry

PDF136KB

Urgent Field Safety Notice for ARCHITECT Free T3 Reagent Kit and ARCHITECT Total T3 Reagent Kit by Abbott Ireland Diagnostics Division

In-vitro diagnostics - immunological products

PDF127KB

Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd.

In-vitro diagnostics - haematological, histological and cytological products

PDF332KB

Urgent Field Safety Notice for BM-Lactate by Roche Diagnostics GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF447KB

Urgent Field Safety Notice for Eurotrol Hemoglobin Controls by Eurotrol B.V.

In-vitro diagnostics - equipment / products for clinical chemistry

PDF64KB

Urgent Field Safety Notice for PROXIMATE® PPH Procedure for Prolapse and Hemorrhoids:; PROXIMATE® HCS Procedure for Prolapse and Hemorrhoids (PPH) by Ethicon Endo-Surgery, LLC.

Medical instruments for use in humans - general instruments

PDF347KB

Urgent Field Safety Notice for TODA AMNIODIAG 5 strip and TODA AMNIODIAG 5 cassette by TODA PHARMA

In-vitro diagnostics - immunological products

PDF225KB

Urgent Field Safety Notice for VITEK 2 ID / AST Card Types by bioMérieux Inc

In-vitro diagnostics - microbiological products

PDF256KB

Urgent Field Safety Notice for Zenzy Arzteingabemodul by Dr. Heni Software GmbH & Co. KG

Medical data processing (software) - others

PDF182KB

Urgent Field Safety Notice for SAPPHIRE administration Sets by ICU Medical

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF389KB

Urgent Field Safety Notice for 3D Optical Coherence Tomography by Topcon Corporation

ophthalmological technology - equipment for ophthalmological diagnostics

PDF2MB

Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy

Non-active implants - special implants

PDF2MB

Urgent Field Safety Notice for PROVERT by PROTEC GmbH & Co. KG

Radiological technology - stationary radiological equipment

PDF69KB

Urgent Field Safety Notice for PROGNOST ES / PROGNOST FS / PROGNOST S. by PROTEC GmbH & Co. KG

Radiological technology - stationary radiological equipment

PDF69KB

Urgent Field Safety Notice for Edwards Commander Delivery System by Edwards Lifesciences LLC

Injections / Infusions / Transfusions / Dialysis - catheters

PDF320KB

Urgent Field Safety Notice for Valtitude, Resonate, Momentum, Autogen, Inogen, Visionist, Vigilant, Charisma, Dynagen, Origen by Boston Scientific Corp., Scimed

Active implantable medical devices - defibrillators

PDF288KB

Urgent Field Safety Notice for Endothelmikroskop I Specular Microscope CEM-530 by NIDEK CO., LTD

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

PDF57KB

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

Radiotherapy / Radiation protection - radiotherapy treatment planning systems

PDF86KB

Urgent Field Safety Notice for Valitude, Accolade, Essentio, Visionist, Proponent, Altrua 2 by Boston Scientific CRM

Active implantable medical devices - cardiac pacemakers

PDF599KB

Urgent Field Safety Notice for CFF05 5x75mm Kii Fios Advanced Fixation Access Sys by Applied Medical Resources

Medical instruments for use in humans - visceral surgery

PDF170KB

Urgent Field Safety Notice for GRP-Handgriff by MGB Endoskopische Geräte GmbH Berlin

Medical electronics / Electromedical devices - electrotherapy

PDF91KB

Urgent Field Safety Notice for BonAlive putty MIS by BonAlive Biomaterials Ltd

Non-active implants - materials for implants

PDF113KB

Urgent Field Safety Notice for Patientenset für R100 by Metran Co.Ltd.

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF309KB

Urgent Field Safety Notice for Septiflow Circuit by Altera Tibbi Maiz.San.ve Tic.A.S Turan Mah.

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF1MB

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

Medical electronics / Electromedical devices - electrodiagnostics

PDF146KB

Urgent Field Safety Notice for SMF Stem With Stiktite by Smith & Nephew, Inc.,

Non-active implants - bone surgery

PDF79KB

Urgent Field Safety Notice for COBRA Fusion 150 Minimally Invasive Ablation System by AtriCure, Inc.

Medical electronics / Electromedical devices - electrotherapy

PDF804KB

Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc.

Medical electronics / Electromedical devices - electrotherapy

PDF126KB

Urgent Field Safety Notice for EMS-Stretcher by Bucher Leichtbau AG

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

PDF1MB

Urgent Field Safety Notice for Interactive Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC.

Dental products - dental implants

PDF401KB

Urgent Field Safety Notice for UROSKOP OMNIA and UROSKOP OMNIA MAX by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology - radiological equipment for urological diagnostics

PDF4MB

Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare

Medical electronics / Electromedical devices - electrodiagnostics

PDF207KB

Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sensors by Mölnlycke Health Care AB

Injections / Infusions / Transfusions / Dialysis - catheters

PDF352KB

Urgent Field Safety Notice for Pall Ultipor 25 Breathing System Filter by Pall Medical, A Division of Pall International Sàrl

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF2MB

Urgent Field Safety Notice for Verso Shoulder Humeral Shells and Verso Shoulder Stemmed Humeral by Innovative Design Orthopaedics Limited

Non-active implants - bone surgery

PDF3MB

Urgent Field Safety Notice for DiaSpect Hemoglobin T-LOW by DiaSpect Medical GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF3MB

Urgent Field Safety Notice for Zirkon Primer by GDF Gesellschaft für Dentale Forschung und Innovationen GmbH

Dental products - dental material

PDF119KB

Urgent Field Safety Notice for Calcium CA3871 by Randox Laboratories Ltd

In-vitro diagnostics - equipment / products for clinical chemistry

PDF1MB

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

In-vitro diagnostics - microbiological products

PDF210KB

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

PDF2MB

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

In-vitro diagnostics - haematological, histological and cytological products

PDF359KB

Urgent Field Safety Notice for UniMatch Plus Software by One Lambda Inc.

In-vitro diagnostics - instruments, apparatuses and systems

PDF126KB

Urgent Field Safety Notice for ADVIA Chemistry XPT System by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics - equipment / products for clinical chemistry

PDF58KB

Urgent Field Safety Notice for NEOselect, NEOonsite - Data Analysis & NEOdb by NEO New Oncology GmbH

In-vitro diagnostics - instruments, apparatuses and systems

PDF107KB

Urgent Field Safety Notice for Enzygnost Syphilis by Siemens Healthcare Diagnostics Products GmbH

In-vitro diagnostics - microbiological products

PDF910KB

Urgent Field Safety Notice for Alaris VP with Guardrails by CareFusion Switzerland 317 Sarl

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF90KB

Urgent Field Safety Notice for Specific IgG4 ELISA by Dr. Fooke-Achterrath Laboratorien GmbH

In-vitro diagnostics - immunological products

PDF130KB

Urgent Field Safety Notice for Xpert GBS by Cepheid

In-vitro diagnostics - microbiological products

PDF1MB

Urgent Field Safety Notice for Stratec GEMINI und Stratec GEMINI Combo by STRATEC SE

In-vitro diagnostics - equipment / products for clinical chemistry

PDF2MB

Urgent Field Safety Notice for WDC Detachement Controller by SEQUENT MEDICAL Inc.

Injections / Infusions / Transfusions / Dialysis - infusion technology

PDF2MB

Urgent Field Safety Notice for Portex Bivona Inner Cannula Tracheostomy Tube by Smiths Medical ASD, Inc. (Plymouth)

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF584KB

Urgent Field Safety Notice for Inferior Vena Cava (IVC) Filter by William Cook Europe ApS

Non-active implants - special implants

PDF1MB

Urgent Field Safety Notice for Dialog iQ by B. Braun Avitum AG

Injections / Infusions / Transfusions / Dialysis - dialysis technology

PDF42KB

Urgent Field Safety Notice for TULIPS by Ardo medical AG

General equipment for medical treatment - others

PDF189KB

Urgent Field Safety Notice for Spine & Trauma 3D by Brainlab AG

Radiological technology - navigation systems

PDF304KB

Urgent Field Safety Notice for GelPOINT® Path Transanal Access Platform by Applied Medical Resources

Dressings / Pads - others

PDF145KB

Urgent Field Safety Notice for SOMATOM Confidence, Edge Plus, Definition Edge, AS by Siemens Healthcare GmbH Computed Tomography (CT)

Radiological technology - CT scanners

PDF4MB

Urgent Field Safety Notice for Aldosterone ALDO-RIACT;T4 OCPG07-T4 and OCPG57-T4; FPSA FPSA-RIACT;PSA PSA-RIACT;Chromogranine A CGA-RIACT; T3 OCPE7-T3 and OCPE57-T3;Chromogranine A CGA-Elisa (Protocole long) by Cisbio Bioassays

In-vitro diagnostics - immunological products

PDF121KB

Urgent Field Safety Notice for BD MAX Enteric Bacterial Panel by GeneOhm Sciences Canada, Inc.

In-vitro diagnostics - microbiological products

PDF209KB

Urgent Field Safety Notice for ARCHITECT Estradiol Reagent, Alinity i Estradiol Reagent Kit by Abbott Ireland Diagnostics Division

In-vitro diagnostics - immunological products

PDF123KB

Urgent Field Safety Notice for IDS-iSYS ACTH by Immunodiagnostic Systems Ltd

In-vitro diagnostics - equipment / products for clinical chemistry

PDF660KB

Urgent Field Safety Notice for cobas p 612 pre-analytical system by Roche Diagnostics GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF385KB

Urgent Field Safety Notice for DHEA ELISA by IBL International GmbH

In-vitro diagnostics - immunological products

PDF151KB

Urgent Field Safety Notice for STA - VWF:RCo by Stago

In-vitro diagnostics - haematological, histological and cytological products

PDF151KB

Urgent Field Safety Notice for t-PSA Rapid Test / Free PSA Rapid Test by Dongguan Bosh Biotechnologies, Ltd.

In-vitro diagnostics - immunological products

PDF4MB

Urgent Field Safety Notice for Pulmonary Vein Ablation Catheter (PVAC) GOLD by Medtronic Ablation Frontiers LLC

Injections / Infusions / Transfusions / Dialysis - catheters

PDF58KB

Urgent Field Safety Notice for CRP FS by DiaSys Diagnostic Systems GmbH

In-vitro diagnostics - immunological products

PDF2MB

Urgent Field Safety Notice for Lactose intolerance quick test by Biohit Oyj

In-vitro diagnostics - microbiological products

PDF5MB

Urgent Field Safety Notice for Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH by Siemens Healthcare Diagnostics, Inc

In-vitro diagnostics - immunological products

PDF56KB

Urgent Field Safety Notice for cobas u 601 / cobas u 701 by Roche Diagnostics GmbH

In-vitro diagnostics - equipment / products for clinical chemistry

PDF534KB

Urgent Field Safety Notice for Optilite C-Reactive Protein Reagent by The Binding Site Group Limited

In-vitro diagnostics - immunological products

PDF573KB

Urgent Field Safety Notice for xTAG Gastrointestinal Pathogen Panel (GPP) by Luminex Molecular Diagnostics, Inc.

In-vitro diagnostics - microbiological products

PDF200KB

Urgent Field Safety Notice for Dako Slide Racks by Dako North America, Inc.

In-vitro diagnostics - instruments, apparatuses and systems

PDF339KB

Urgent Field Safety Notice for WIP'ANIOS PREMIUM/ WIP'ANIOS EXCELTRAVEL by Laboratoires ANIOS (DMD)

General equipment for medical treatment - cleaning / disinfection / sterilisation

PDF329KB

Urgent Field Safety Notice for ACCULAN 4 OSCILLATING SAW STRAIGHT by Aesculap AG

Surgical equipment/ Anaesthesia - surgical equipment

PDF2MB

Urgent Field Safety Notice for UNISEPTA FOAM 2 WIPES by USF Healthcare SA

General equipment for medical treatment - cleaning / disinfection / sterilisation

PDF6MB

Urgent Field Safety Notice for SMARTSTITCH PP CONNECTOR by ArthroCare Corp.

Medical instruments for use in humans - general instruments

PDF87KB

Urgent Field Safety Notice for LifePearl microspheres by MicroVention Europe

Non-active implants - special implants

PDF2MB

Urgent Field Safety Notice for ECG trunk cable by GE Healthcare Finland Oy

Medical electronics / Electromedical devices - electrotherapy

PDF177KB

Urgent Field Safety Notice for Hamilton G5 by Hamilton Medical AG

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF116KB

Urgent Field Safety Notice for CELL-DYN Emerald by Abbott Laboratories

In-vitro diagnostics - haematological, histological and cytological products

PDF113KB

Urgent Field Safety Notice for Reaxon Direct by Medovent GmbH

Non-active implants - other implants

PDF2MB

Urgent Field Safety Notice for Logiq P5 and Logiq A5 by GEULTRASOUND KOREA, LTD

Ultrasonics - ultrasonic diagnostic equipment

PDF174KB

Urgent Field Safety Notice for Cannula needle by Applimed SA

Injections / Infusions / Transfusions / Dialysis - syringes and cannulas

PDF96KB

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

Active implantable medical devices - artificial hearts

PDF147KB

Urgent Field Safety Notice for Heater-Cooler System by LivaNova Deutschland GmbH

Surgical equipment/ Anaesthesia - surgical equipment

PDF54KB

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy

PDF104KB

Urgent Field Safety Notice for DIPHOTERINE - PREVIN by PREVOR

Physical therapy - insufflation technique

PDF253KB

Urgent Field Safety Notice for HeartMate 3 Coring Tool by Thoratec Corporation

Active implantable medical devices - artificial hearts

PDF155KB

Urgent Field Safety Notice for LactoSorb RapidFlap by Biomet Orthopaedic LLC

Non-active implants - bone surgery

PDF212KB

Urgent Field Safety Notice for Stereotacticradiotherapy/MRI System by ViewRay Inc.

Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy

PDF78KB

Urgent Field Safety Notice for LOGIQ P5 by GE ULTRASOUND KOREA, LTD

Ultrasonics - ultrasonic diagnostic equipment

PDF174KB

Urgent Field Safety Notice for Cordis Vista Brite and ADROIT Guiding Catheter by Cordis Corporation

Injections / Infusions / Transfusions / Dialysis - catheters

PDF217KB

Urgent Field Safety Notice for GMK UNI Femur by Medacta International SA

Non-active implants - bone surgery

PDF33KB

Urgent Field Safety Notice for INTRAPUR NEONAT I.V.FILTER 0.2MICRON by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis - filters

PDF44KB

Urgent Field Safety Notice for Centricity Universal Viewer by GEHEALTHCARE INTEGRATED IT SOLUTIONS Inc

Medical data processing (software) - data processing facilities for image processing

PDF299KB

Urgent Field Safety Notice for Certofix Quattro by B. Braun Melsungen AG

Injections / Infusions / Transfusions / Dialysis - catheters

PDF71KB

Urgent Field Safety Notice for MultiDiagnost Eleva with Flat Detector, Allura Xpe by Philips Medical Systems Nederland B.V

Radiological technology - stationary radiological equipment

PDF257KB

Urgent Field Safety Notice for MultiDiagnost Eleva - UroDiagnost Eleva - OmniDi by Philips Medical Systems Nederland B.V

Radiological technology - stationary radiological equipment

PDF373KB

Urgent Field Safety Notice for EnFlow by CareFusion 211 Respiratory Systems

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

PDF91KB

Urgent Field Safety Notice for RUSCH Connectors Bulk for Breathing Circuits by Teleflex (Perak West Malaysia)

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF347KB

Urgent Field Safety Notice for Philips PageWriter TC Cardiographs (TC20/30/50/70) by Philips Medical Systems

Medical electronics / Electromedical devices - electrodiagnostics

PDF268KB

Urgent Field Safety Notice for GXT NA Extraction Kit by Hain Lifescience GmbH

In-vitro diagnostics - microbiological products

PDF198KB

Urgent Field Safety Notice for balanSys Femur Holder by Mathys AG Bettlach

Medical instruments for use in humans - bone surgery

PDF139KB

Urgent Field Safety Notice for NSE PTA Balloon Catheter GDM01 by Goodman Co. Ltd

Injections / Infusions / Transfusions / Dialysis - catheters

PDF4MB

Urgent Field Safety Notice for URINALYSIS CONTROL - LEVEL 2 by Randox Laboratories Ltd

In-vitro diagnostics - equipment / products for clinical chemistry

PDF2MB

Urgent Field Safety Notice for VICRYL Suture and VICRYL Plus Suture Products by Ethicon Endo-Surgery, LLC.

Dressings / Pads - surgical sutures, vascular loops etc.

PDF289KB

Urgent Field Safety Notice for Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module by Abbott International RA Vigilance Team

In-vitro diagnostics - haematological, histological and cytological products

PDF160KB

Urgent Field Safety Notice for PARI LC SPRINT Tracheo by PARI GmbH

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF173KB

Urgent Field Safety Notice for Echinococcus IgG ELISA by IBL International GmbH

In-vitro diagnostics - microbiological products

PDF159KB

Urgent Field Safety Notice for SONOLITH I-SYS by EDAP TMS France S.A.

Ultrasonics - ultrasonic therapeutic equipment

PDF637KB

Urgent Field Safety Notice for ARIES products by Luminex Corporation

In-vitro diagnostics - microbiological products

PDF4MB

Urgent Field Safety Notice for FTD Fever and rash by Fast Track Diagnostics Luxembourg S.à.r.l

In-vitro diagnostics - microbiological products

PDF251KB

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

PDF275KB

Urgent Field Safety Notice for FilmArray Gastrointestinal (GI) Panel by BioFire Diagnostics, LLC

In-vitro diagnostics - microbiological products

PDF484KB

Urgent Field Safety Notice for ENAcombi (ORG 514) by Orgentec Diagnostika GmbH

In-vitro diagnostics - immunological products

PDF806KB

Urgent Field Safety Notice for recomLine Helicobacter 2.0 IgG/IgA by Mikrogen GmbH

In-vitro diagnostics - microbiological products

PDF2MB

Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics - equipment / products for clinical chemistry

PDF69KB

Urgent Field Safety Notice for Rebound HRD / HRD-V by ARB Medical LLC

Non-active implants - special implants

PDF51KB

Urgent Field Safety Notice for PRIMUS, ONCOR, ARTISTE by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology

Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy

PDF97KB

Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology - mobile radiological diagnostic facilities

PDF1MB

Urgent Field Safety Notice for PROBE Titanschale 60 mm links Lasche 60 mm by PETER BREHM GmbH

Medical instruments for use in humans - bone surgery

PDF388KB

Urgent Field Safety Notice for Alinity i,c Processing Modules, Alinity s system by Abbott International RA Vigilance Team

In-vitro diagnostics - equipment / products for clinical chemistry

PDF276KB

Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY)

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

PDF695KB

Urgent Field Safety Notice for CLEO by Hoggi GmbH

Orthopaedic / Rehabilitation technology - mobility aids

PDF565KB

Urgent Field Safety Notice for PADSY-Holter by Medset Medizintechnik GmbH

Medical electronics / Electromedical devices - electrodiagnostics

PDF3MB

Urgent Field Safety Notice for RT Elements by Brainlab AG

Radiotherapy / Radiation protection - radiotherapy treatment planning systems

PDF409KB

Urgent Field Safety Notice for AIR Anterior Array by GE Healthcare Coils

Electromedical fields - equipment for MR tomography

PDF118KB

Urgent Field Safety Notice for Geistlich Bio-Oss Pen by Geistlich Pharma AG

Non-active implants - materials for implants

PDF110KB

Urgent Field Safety Notice for Endo Clinch II Auto Suture Grasper 5mm and Endo Grasp Auto Suture Grasper 5mm by Covidien llc

Medical instruments for use in humans - general instruments

PDF401KB

Urgent Field Safety Notice for Cios Spin by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology - mobile radiological diagnostic facilities

PDF140KB

Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda)

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF199KB

Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology - mobile radiological diagnostic facilities

PDF168KB

Urgent Field Safety Notice for BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM by Invacare Deutschland GmbH

Orthopaedic / Rehabilitation technology - mobility aids

PDF162KB

Urgent Field Safety Notice for S. AIA-PACK Homocysteine by Tosoh Corporation

In-vitro diagnostics - equipment / products for clinical chemistry

PDF243KB

Urgent Field Safety Notice for cobas 8000 by Hitachi High-Technologies Corporation

In-vitro diagnostics - equipment / products for clinical chemistry

PDF494KB

Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC

In-vitro diagnostics - microbiological products

PDF483KB

Urgent Field Safety Notice for MAJ-209 SINGLE USE SUCTION VALVE by Olympus Medical Systems Corp.

Optics / Precision engineering - endoscopes

PDF216KB

Urgent Field Safety Notice for S. AIA-PACK ACTH by Tosoh Corporation

In-vitro diagnostics - immunological products

PDF243KB

Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC

Active implantable medical devices - cardiac pacemakers

PDF2MB

Urgent Field Safety Notice for Ventrikelkatheter by Christoph Miethke GmbH & CoKG

Non-active implants - special implants

PDF2MB

Urgent Field Safety Notice for Detector Mounting Screws for Nuclear Medicine Systems by GE Medical Systems Israel, Functional Imaging

Electromedical fields - equipment for MR tomography

PDF173KB

Urgent Field Safety Notice for Breathing circuits VentStar Helix by Dräger Medical GmbH jetzt Drägerwerk AG & Co. KGaA

Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply

PDF1MB

Urgent Field Safety Notice for MRIdian Linac System by ViewRay Inc.

Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy

PDF9MB

Urgent Field Safety Notice for Bohrloch Reservoir Set by Christoph Miethke GmbH & Co. KG

Non-active implants - special implants

PDF2MB