Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2019 – 31.03.2019
Опубліковано 27.06.2019 о 11:46
- 01.07
Urgent Field Safety Notice for Mayfield Skull Clamp by IntegraLifeSciences Mayfield
Surgical equipment/ Anaesthesia – surgical equipment
- 01.07
Urgent Field Safety Notice for Navina rectal catheter regular + associated device by Wellspect HealthCare
Physical therapy – hydrotherapy
- 01.07
Urgent Field Safety Notice for CW002, 5x42CM EPIX ES PRB SMK EVAC LHOOK by Applied Medical Resources Corporation
Optics / Precision engineering – endoscopes
- 01.07
Urgent Field Safety Notice for Octenidol md Mundspüllösung by MPC International S.A.
Dental products – others
- 01.07
Urgent Field Safety Notice for Eye Station by Merge Healthcare
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
- 01.07
Urgent Field Safety Notice for IMTEC-b2-Glycoprotein I-Antibodies IgG by HUMAN Gesellschaft für Biochemica und Diagnostica mbH
In-vitro diagnostics – immunological products
- 01.07
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
- 01.07
Urgent Field Safety Notice for Celsite Safety by B.BRAUN MEDICAL Saint Cloud
Non-active implants – special implants
- 01.10
Urgent Field Safety Notice for Alinity i Processing Module by Abbott GmbH & Co. KG
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.09
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
- 01.09
Urgent Field Safety Notice for ALLOFIT ALLO-C SCR PLUG STER by Zimmer GmbH
Non-active implants – bone surgery
- 01.09
Urgent Field Safety Notice for Entuit Secure Gastrointestinal Suture Anchor Set by Cook Incorporated
Non-active implants – special implants
- 01.08
Urgent Field Safety Notice for HS Curing light by Henry Schein Inc.
Dental products – equipment
- 01.08
Urgent Field Safety Notice for Interactive Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC.
Dental products – dental implants
- 01.08
Urgent Field Safety Notice for Vertex Orthoplast by Vertex-Dental B.V.
Dental products – dental material
- 01.08
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
- 01.08
Urgent Field Safety Notice for Efficia 3/5 ECG Trunk Cable, AAMI/IEC by Philips Medical Systems
Medical electronics / Electromedical devices – electrotherapy
- 01.07
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
- 01.07
Urgent Field Safety Notice for Mobi-C by LDR MEDICAL
Non-active implants – bone surgery
- 01.07
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
- 01.07
Urgent Field Safety Notice for Minstrel by ArjoHuntleigh AB
General equipment for medical treatment – ward equipment and equipment for emergency medical services
- 01.07
Urgent Field Safety Notice for Max VPC Instrument Tray & Screw Caddy by Biomet Orthopedics, LLC
Medical instruments for use in humans – bone surgery
- 01.07
Urgent Field Safety Notice for IONTRIS by Siemens Healthcare GmbH, Advanced Therapies, Particle Therapy
Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
- 01.10
Urgent Field Safety Notice for Fructosamine Calibrators and Controls by Randox Laboratories Ltd
In-vitro diagnostics – immunological products
- 01.10
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
- 01.10
Urgent Field Safety Notice for VITROS Chemistry Products VALP Slides by Ortho-Clinical Diagnostics, Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.10
Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
- 01.10
Urgent Field Safety Notice for Various by Abbott Ireland Diagnostics Division
In-vitro diagnostics – immunological products
- 01.10
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
- 01.10
Urgent Field Safety Notice for Quo-Test A1C Test Kit by EKF-diagnostic GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.10
Urgent Field Safety Notice for Eclipse Treatment Planning System by Varian Medical Systems, Inc.
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
- 01.10
Urgent Field Safety Notice for CLEAN by Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.10
Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation
Active implantable medical devices – artificial hearts
- 01.10
Urgent Field Safety Notice for BILT3,IGM-2, LACT2 und Lactate by Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.10
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
- 01.10
Urgent Field Safety Notice for Architect B12 Reagenz by Abbott Ireland Diagnostics Division
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.10
Urgent Field Safety Notice for STACLOT LA by Stago
In-vitro diagnostics – haematological, histological and cytological products
- 01.10
Urgent Field Safety Notice for Centricity Universal Viewer by GEHEALTHCARE INTEGRATED IT SOLUTIONS Inc
Medical data processing (software) – data processing facilities for image processing
- 01.18
Urgent Field Safety Notice for ECLIPSE 2L by BALT Extrusion
Injections / Infusions / Transfusions / Dialysis – catheters
- 01.17
Urgent Field Safety Notice for Leica M220 F12 by Leica Microsystems (Schweiz) AG
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
- 01.17
Urgent Field Safety Notice for Percuvance 29cm Shaft Percuvance 36cm Shaft by Teleflex Medical USA
Optics / Precision engineering – endoscopes
- 01.16
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
- 01.16
Urgent Field Safety Notice for Reverse Loaded Wire Guides by Cook Incorporated
Injections / Infusions / Transfusions / Dialysis – catheters
- 01.16
Urgent Field Safety Notice for Lambotte-Meißel, 20mm by aap Implantate AG
Medical instruments for use in humans – bone surgery
- 01.16
Urgent Field Safety Notice for Vectris by Medtronic Inc
Active implantable medical devices – biostimulators
- 01.14
Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare
Medical electronics / Electromedical devices – electrotherapy
- 01.14
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
- 01.14
Urgent Field Safety Notice for Senographe Crystal Nova by GEULTRASOUND KOREA, LTD
Radiological technology – radiological equipment for mammographic diagnostics
- 01.14
Urgent Field Safety Notice for Reprocessed Biosense Webster Lasso 2515 NAV eco Va by Stryker Sustainability Solutions
Injections / Infusions / Transfusions / Dialysis – catheters
- 01.11
Urgent Field Safety Notice for Accu-Chek Insight by Roche Diabetes Care GmbH
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 01.11
Urgent Field Safety Notice for smartPen, 2 Tasten, ø2,4mm, 4 by Gebrüder Martin GmbH & Co. KG
Medical electronics / Electromedical devices – electrotherapy
- 01.11
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
- 01.11
Urgent Field Safety Notice for UNIMED Medical Needle by UNIMED S.A.
Injections / Infusions / Transfusions / Dialysis – injection kits
- 01.24
Urgent Field Safety Notice for Instrument Tray, Basic T2 Femur Long by Stryker Trauma Kiel
Medical instruments for use in humans – bone surgery
- 01.24
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
- 01.23
Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd.
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 01.23
Urgent Field Safety Notice for Absaug-, S.ül- oder Drainageschlauch by Silikon-Technik Siltec GmbH & Co. KG
Optics / Precision engineering – endoscopes
- 01.23
Urgent Field Safety Notice for Nellix (Version 3.5), Endovascular Aneurysm Sealing System by Endologix, Inc.
Non-active implants – other implants
- 01.23
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
- 01.23
Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah
Injections / Infusions / Transfusions / Dialysis – catheters
- 01.23
Urgent Field Safety Notice for Efficia CM10, CM12, CM100, CM120, CM150 by Philips Medical Systems
Medical electronics / Electromedical devices – electrodiagnostics
- 01.23
Urgent Field Safety Notice for Spectra Optia System by Terumo BCT, Inc
Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures
- 01.22
Urgent Field Safety Notice for Ancora, Novaplus T and Gold T Normal by Eurogine S.L.
Contraception – intrauterine device
- 01.22
Urgent Field Safety Notice for NIM-ECLIPSE System by Medtronic Xomed Inc.
Medical electronics / Electromedical devices – electrodiagnostics
- 01.22
Urgent Field Safety Notice for Ziehm Vision RFD; Vision RFD 3D; Ziehm Solo FD by Ziehm Imaging GmbH
Radiological technology – mobile radiological diagnostic facilities
- 01.22
Urgent Field Safety Notice for Burr, Oval, 12 Flute, 5.5 mm x 13 cmby Arthrex INC
Surgical equipment/ Anaesthesia – surgical equipment
- 01.22
Urgent Field Safety Notice for Celsite Implantofix by B.BRAUN MEDICAL
Non-active implants – special implants
- 01.22
Urgent Field Safety Notice for Ingenuity TF PET/CT by PHILIPS MEDICAL SYSTEMS (Cleveland), Inc. (CL)
Radiological technology – CT scanners
- 01.31
Urgent Field Safety Notice for Oxoid BrillianceT ESBL/Brilliance CRE Bi-Plate by Thermo Fisher Scientific – Microbiology Central Reporting
In-vitro diagnostics – microbiological products
- 01.31
Urgent Field Safety Notice for Software für Immunomate by Institut VirionSerion GmbH
In-vitro diagnostics – instruments, apparatuses and systems
- 01.31
Urgent Field Safety Notice for Oxoid M.I.C.E Meropenem MA0121 by Thermo Fisher Scientific Microbiology Basingstoke
In-vitro diagnostics – microbiological products
- 01.31
Urgent Field Safety Notice for TGS TA EBV Contra! Set by Technogenetics s.r.l.
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.30
Urgent Field Safety Notice for Breathing Circuits/Anesthesia Sets/Pack2Go/Set2Go by Drägerwerk AG & Co. KGaA
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 01.30
Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V.
Radiological technology – stationary radiological equipment
- 01.30
Urgent Field Safety Notice for Philips Hemodynamic Application R1.0 by Philips Medical Systems Nederland B.V.
Medical electronics / Electromedical devices – electrodiagnostics
- 01.29
Urgent Field Safety Notice for MAKO Vizadisc Knee/Hip Procedure Tracking Kit by MAKO Surgical Corp.
Surgical equipment/ Anaesthesia – surgical equipment
- 01.29
Urgent Field Safety Notice for Fitbone TAA by Wittenstein intens GmbH
Active implantable medical devices – others
- 01.29
Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems
Medical electronics / Electromedical devices – electrodiagnostics
- 01.29
Urgent Field Safety Notice for Harmonic ACE Curved Shears Insert by Intuitive Surgical, Inc.
Surgical equipment/ Anaesthesia – surgical equipment
- 01.29
Urgent Field Safety Notice for Agile Biliary RX Fully Covered Stent System by Boston Scientific Corporation Marlborough
Non-active implants – special implants
- 01.25
Urgent Field Safety Notice for Suction Catheters, Gastro-enteral Tubes by ConvaTec Limited Deeside
Surgical equipment/ Anaesthesia – surgical equipment
- 01.24
Urgent Field Safety Notice for Acusnare Polypectomy Snares by Cook Endoscopy
Optics / Precision engineering – endoscopes
- 01.24
Urgent Field Safety Notice for CareLink Programmer; CareLink Encore Programmer by Medtronic Inc
Active implantable medical devices – defibrillators
- 02.05
Urgent Field Safety Notice for LOGIQ P6 systems by GE Medical Systems Information Technologies GmbH
Ultrasonics – ultrasonic diagnostic equipment
- 02.05
Urgent Field Safety Notice for Padlock Clip defect closure system by United States Endoscopy Group, Inc.
Medical instruments for use in humans – general instruments
- 02.05
Urgent Field Safety Notice for AXIUS Blower Mister by Maquet Cardiovascular
Optics / Precision engineering – endoscopes
- 02.05
Urgent Field Safety Notice for Acuson NX2 , NX2 Elite, NX3, NX3 Elite, by Siemens Medical Solutions USA, Inc. Ultrasound
Ultrasonics – ultrasonic diagnostic equipment
- 02.04
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
- 02.01
Urgent Field Safety Notice for Celsite Safety by B.BRAUN MEDICAL Saint Cloud
Non-active implants – special implants
- 02.01
Urgent Field Safety Notice for Cortical Screw 3.5 by aap Implantate AG
Non-active implants – bone surgery
- 01.31
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
- 01.31
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
- 01.31
Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd.
In-vitro diagnostics – haematological, histological and cytological products
- 01.31
Urgent Field Safety Notice for BM-Lactate by Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.31
Urgent Field Safety Notice for Eurotrol Hemoglobin Controls by Eurotrol B.V.
In-vitro diagnostics – equipment / products for clinical chemistry
- 01.31
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
- 01.31
Urgent Field Safety Notice for TODA AMNIODIAG 5 strip and TODA AMNIODIAG 5 cassette by TODA PHARMA
In-vitro diagnostics – immunological products
- 01.31
Urgent Field Safety Notice for VITEK 2 ID / AST Card Types by bioMérieux Inc
In-vitro diagnostics – microbiological products
- 02.13
Urgent Field Safety Notice for Zenzy Arzteingabemodul by Dr. Heni Software GmbH & Co. KG
Medical data processing (software) – others
- 02.12
Urgent Field Safety Notice for SAPPHIRE administration Sets by ICU Medical
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 02.12
Urgent Field Safety Notice for 3D Optical Coherence Tomography by Topcon Corporation
ophthalmological technology – equipment for ophthalmological diagnostics
- 02.12
Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy
Non-active implants – special implants
- 02.12
Urgent Field Safety Notice for PROVERT by PROTEC GmbH & Co. KG
Radiological technology – stationary radiological equipment
- 02.12
Urgent Field Safety Notice for PROGNOST ES / PROGNOST FS / PROGNOST S. by PROTEC GmbH & Co. KG
Radiological technology – stationary radiological equipment
- 02.11
Urgent Field Safety Notice for Edwards Commander Delivery System by Edwards Lifesciences LLC
Injections / Infusions / Transfusions / Dialysis – catheters
- 02.11
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
- 02.11
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)
- 02.08
Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
- 02.08
Urgent Field Safety Notice for Valitude, Accolade, Essentio, Visionist, Proponent, Altrua 2 by Boston Scientific CRM
Active implantable medical devices – cardiac pacemakers
- 02.07
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
- 02.06
Urgent Field Safety Notice for GRP-Handgriff by MGB Endoskopische Geräte GmbH Berlin
Medical electronics / Electromedical devices – electrotherapy
- 02.06
Urgent Field Safety Notice for BonAlive putty MIS by BonAlive Biomaterials Ltd
Non-active implants – materials for implants
- 02.06
Urgent Field Safety Notice for Patientenset für R100 by Metran Co.Ltd.
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 02.20
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
- 02.20
Urgent Field Safety Notice for Carescape One by GE Medical Systems Information Technologies, Inc.
Medical electronics / Electromedical devices – electrodiagnostics
- 02.20
Urgent Field Safety Notice for SMF Stem With Stiktite by Smith & Nephew, Inc.,
Non-active implants – bone surgery
- 02.19
Urgent Field Safety Notice for COBRA Fusion 150 Minimally Invasive Ablation System by AtriCure, Inc.
Medical electronics / Electromedical devices – electrotherapy
- 02.19
Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc.
Medical electronics / Electromedical devices – electrotherapy
- 02.15
Urgent Field Safety Notice for EMS-Stretcher by Bucher Leichtbau AG
General equipment for medical treatment – ward equipment and equipment for emergency medical services
- 02.15
Urgent Field Safety Notice for Interactive Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC.
Dental products – dental implants
- 02.15
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
- 02.14
Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare
Medical electronics / Electromedical devices – electrodiagnostics
- 02.14
Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sensors by Mölnlycke Health Care AB
Injections / Infusions / Transfusions / Dialysis – catheters
- 02.14
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
- 02.14
Urgent Field Safety Notice for Verso Shoulder Humeral Shells and Verso Shoulder Stemmed Humeral by Innovative Design Orthopaedics Limited
Non-active implants – bone surgery
- 02.21
Urgent Field Safety Notice for DiaSpect Hemoglobin T-LOW by DiaSpect Medical GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.21
Urgent Field Safety Notice for Zirkon Primer by GDF Gesellschaft für Dentale Forschung und Innovationen GmbH
Dental products – dental material
- 02.21
Urgent Field Safety Notice for Calcium CA3871 by Randox Laboratories Ltd
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.21
Urgent Field Safety Notice for Mentype MycoDermQS Lateral Flow by Biotype Diagnostic GmbH
In-vitro diagnostics – microbiological products
- 02.21
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
- 02.21
Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH& Co. KG
In-vitro diagnostics – haematological, histological and cytological products
- 02.21
Urgent Field Safety Notice for UniMatch Plus Software by One Lambda Inc.
In-vitro diagnostics – instruments, apparatuses and systems
- 02.21
Urgent Field Safety Notice for ADVIA Chemistry XPT System by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.21
Urgent Field Safety Notice for NEOselect, NEOonsite – Data Analysis & NEOdb by NEO New Oncology GmbH
In-vitro diagnostics – instruments, apparatuses and systems
- 02.21
Urgent Field Safety Notice for Enzygnost Syphilis by Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – microbiological products
- 02.21
Urgent Field Safety Notice for Alaris VP with Guardrails by CareFusion Switzerland 317 Sarl
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 02.21
Urgent Field Safety Notice for Specific IgG4 ELISA by Dr. Fooke-Achterrath Laboratorien GmbH
In-vitro diagnostics – immunological products
- 02.21
Urgent Field Safety Notice for Xpert GBS by Cepheid
In-vitro diagnostics – microbiological products
- 02.21
Urgent Field Safety Notice for Stratec GEMINI und Stratec GEMINI Combo by STRATEC SE
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.20
Urgent Field Safety Notice for WDC Detachement Controller by SEQUENT MEDICAL Inc.
Injections / Infusions / Transfusions / Dialysis – infusion technology
- 02.26
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
- 02.26
Urgent Field Safety Notice for Inferior Vena Cava (IVC) Filter by William Cook Europe ApS
Non-active implants – special implants
- 02.26
Urgent Field Safety Notice for Dialog iQ by B. Braun Avitum AG
Injections / Infusions / Transfusions / Dialysis – dialysis technology
- 02.26
Urgent Field Safety Notice for TULIPS by Ardo medical AG
General equipment for medical treatment – others
- 02.26
Urgent Field Safety Notice for Spine & Trauma 3D by Brainlab AG
Radiological technology – navigation systems
- 02.25
Urgent Field Safety Notice for GelPOINT® Path Transanal Access Platform by Applied Medical Resources
Dressings / Pads – others
- 02.25
Urgent Field Safety Notice for SOMATOM Confidence, Edge Plus, Definition Edge, AS by Siemens Healthcare GmbH Computed Tomography (CT)
Radiological technology – CT scanners
- 02.21
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
- 02.21
Urgent Field Safety Notice for BD MAX Enteric Bacterial Panel by GeneOhm Sciences Canada, Inc.
In-vitro diagnostics – microbiological products
- 02.21
Urgent Field Safety Notice for ARCHITECT Estradiol Reagent, Alinity i Estradiol Reagent Kit by Abbott Ireland Diagnostics Division
In-vitro diagnostics – immunological products
- 02.21
Urgent Field Safety Notice for IDS-iSYS ACTH by Immunodiagnostic Systems Ltd
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.21
Urgent Field Safety Notice for cobas p 612 pre-analytical system by Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 02.21
Urgent Field Safety Notice for DHEA ELISA by IBL International GmbH
In-vitro diagnostics – immunological products
- 02.21
Urgent Field Safety Notice for STA – VWF:RCo by Stago
In-vitro diagnostics – haematological, histological and cytological products
- 02.21
Urgent Field Safety Notice for t-PSA Rapid Test / Free PSA Rapid Test by Dongguan Bosh Biotechnologies, Ltd.
In-vitro diagnostics – immunological products
- 03.07
Urgent Field Safety Notice for Pulmonary Vein Ablation Catheter (PVAC) GOLD by Medtronic Ablation Frontiers LLC
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.06
Urgent Field Safety Notice for CRP FS by DiaSys Diagnostic Systems GmbH
In-vitro diagnostics – immunological products
- 03.06
Urgent Field Safety Notice for Lactose intolerance quick test by Biohit Oyj
In-vitro diagnostics – microbiological products
- 03.06
Urgent Field Safety Notice for Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH by Siemens Healthcare Diagnostics, Inc
In-vitro diagnostics – immunological products
- 03.06
Urgent Field Safety Notice for cobas u 601 / cobas u 701 by Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.06
Urgent Field Safety Notice for Optilite C-Reactive Protein Reagent by The Binding Site Group Limited
In-vitro diagnostics – immunological products
- 03.06
Urgent Field Safety Notice for xTAG Gastrointestinal Pathogen Panel (GPP) by Luminex Molecular Diagnostics, Inc.
In-vitro diagnostics – microbiological products
- 03.06
Urgent Field Safety Notice for Dako Slide Racks by Dako North America, Inc.
In-vitro diagnostics – instruments, apparatuses and systems
- 03.06
Urgent Field Safety Notice for WIP’ANIOS PREMIUM/ WIP’ANIOS EXCELTRAVEL by Laboratoires ANIOS (DMD)
General equipment for medical treatment – cleaning / disinfection / sterilisation
- 02.28
Urgent Field Safety Notice for ACCULAN 4 OSCILLATING SAW STRAIGHT by Aesculap AG
Surgical equipment/ Anaesthesia – surgical equipment
- 02.27
Urgent Field Safety Notice for UNISEPTA FOAM 2 WIPES by USF Healthcare SA
General equipment for medical treatment – cleaning / disinfection / sterilisation
- 02.27
Urgent Field Safety Notice for SMARTSTITCH PP CONNECTOR by ArthroCare Corp.
Medical instruments for use in humans – general instruments
- 02.27
Urgent Field Safety Notice for LifePearl microspheres by MicroVention Europe
Non-active implants – special implants
- 02.27
Urgent Field Safety Notice for ECG trunk cable by GE Healthcare Finland Oy
Medical electronics / Electromedical devices – electrotherapy
- 02.26
Urgent Field Safety Notice for Hamilton G5 by Hamilton Medical AG
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.15
Urgent Field Safety Notice for CELL-DYN Emerald by Abbott Laboratories
In-vitro diagnostics – haematological, histological and cytological products
- 03.14
Urgent Field Safety Notice for Reaxon Direct by Medovent GmbH
Non-active implants – other implants
- 03.14
Urgent Field Safety Notice for Logiq P5 and Logiq A5 by GEULTRASOUND KOREA, LTD
Ultrasonics – ultrasonic diagnostic equipment
- 03.14
Urgent Field Safety Notice for Cannula needle by Applimed SA
Injections / Infusions / Transfusions / Dialysis – syringes and cannulas
- 03.14
Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
Active implantable medical devices – artificial hearts
- 03.14
Urgent Field Safety Notice for Heater-Cooler System by LivaNova Deutschland GmbH
Surgical equipment/ Anaesthesia – surgical equipment
- 03.14
Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
- 03.14
Urgent Field Safety Notice for DIPHOTERINE – PREVIN by PREVOR
Physical therapy – insufflation technique
- 03.14
Urgent Field Safety Notice for HeartMate 3 Coring Tool by Thoratec Corporation
Active implantable medical devices – artificial hearts
- 03.14
Urgent Field Safety Notice for LactoSorb RapidFlap by Biomet Orthopaedic LLC
Non-active implants – bone surgery
- 03.14
Urgent Field Safety Notice for Stereotacticradiotherapy/MRI System by ViewRay Inc.
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
- 03.11
Urgent Field Safety Notice for LOGIQ P5 by GE ULTRASOUND KOREA, LTD
Ultrasonics – ultrasonic diagnostic equipment
- 03.11
Urgent Field Safety Notice for Cordis Vista Brite and ADROIT Guiding Catheter by Cordis Corporation
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.08
Urgent Field Safety Notice for GMK UNI Femur by Medacta International SA
Non-active implants – bone surgery
- 03.08
Urgent Field Safety Notice for INTRAPUR NEONAT I.V.FILTER 0.2MICRON by B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis – filters
- 03.19
Urgent Field Safety Notice for Centricity Universal Viewer by GEHEALTHCARE INTEGRATED IT SOLUTIONS Inc
Medical data processing (software) – data processing facilities for image processing
- 03.19
Urgent Field Safety Notice for Certofix Quattro by B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.18
Urgent Field Safety Notice for MultiDiagnost Eleva with Flat Detector, Allura Xpe by Philips Medical Systems Nederland B.V
Radiological technology – stationary radiological equipment
- 03.18
Urgent Field Safety Notice for MultiDiagnost Eleva – UroDiagnost Eleva – OmniDi by Philips Medical Systems Nederland B.V
Radiological technology – stationary radiological equipment
- 03.18
Urgent Field Safety Notice for EnFlow by CareFusion 211 Respiratory Systems
Injections / Infusions / Transfusions / Dialysis – equipment for collecting blood products and peripheral stem cells
- 03.18
Urgent Field Safety Notice for RUSCH Connectors Bulk for Breathing Circuits by Teleflex (Perak West Malaysia)
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.18
Urgent Field Safety Notice for Philips PageWriter TC Cardiographs (TC20/30/50/70) by Philips Medical Systems
Medical electronics / Electromedical devices – electrodiagnostics
- 03.15
Urgent Field Safety Notice for GXT NA Extraction Kit by Hain Lifescience GmbH
In-vitro diagnostics – microbiological products
- 03.15
Urgent Field Safety Notice for balanSys Femur Holder by Mathys AG Bettlach
Medical instruments for use in humans – bone surgery
- 03.15
Urgent Field Safety Notice for NSE PTA Balloon Catheter GDM01 by Goodman Co. Ltd
Injections / Infusions / Transfusions / Dialysis – catheters
- 03.15
Urgent Field Safety Notice for URINALYSIS CONTROL – LEVEL 2 by Randox Laboratories Ltd
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.15
Urgent Field Safety Notice for VICRYL Suture and VICRYL Plus Suture Products by Ethicon Endo-Surgery, LLC.
Dressings / Pads – surgical sutures, vascular loops etc.
- 03.15
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
- 03.15
Urgent Field Safety Notice for PARI LC SPRINT Tracheo by PARI GmbH
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.15
Urgent Field Safety Notice for Echinococcus IgG ELISA by IBL International GmbH
In-vitro diagnostics – microbiological products
- 03.26
Urgent Field Safety Notice for SONOLITH I-SYS by EDAP TMS France S.A.
Ultrasonics – ultrasonic therapeutic equipment
- 03.25
Urgent Field Safety Notice for ARIES products by Luminex Corporation
In-vitro diagnostics – microbiological products
- 03.25
Urgent Field Safety Notice for FTD Fever and rash by Fast Track Diagnostics Luxembourg S.à.r.l
In-vitro diagnostics – microbiological products
- 03.25
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
- 03.25
Urgent Field Safety Notice for FilmArray Gastrointestinal (GI) Panel by BioFire Diagnostics, LLC
In-vitro diagnostics – microbiological products
- 03.25
Urgent Field Safety Notice for ENAcombi (ORG 514) by Orgentec Diagnostika GmbH
In-vitro diagnostics – immunological products
- 03.25
Urgent Field Safety Notice for recomLine Helicobacter 2.0 IgG/IgA by Mikrogen GmbH
In-vitro diagnostics – microbiological products
- 03.25
Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.22
Urgent Field Safety Notice for Rebound HRD / HRD-V by ARB Medical LLC
Non-active implants – special implants
- 03.22
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
- 03.21
Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP)
Radiological technology – mobile radiological diagnostic facilities
- 03.21
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
- 03.21
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
- 03.21
Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY)
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
- 03.20
Urgent Field Safety Notice for CLEO by Hoggi GmbH
Orthopaedic / Rehabilitation technology – mobility aids
- 03.28
Urgent Field Safety Notice for PADSY-Holter by Medset Medizintechnik GmbH
Medical electronics / Electromedical devices – electrodiagnostics
- 03.28
Urgent Field Safety Notice for RT Elements by Brainlab AG
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
- 03.28
Urgent Field Safety Notice for AIR Anterior Array by GE Healthcare Coils
Electromedical fields – equipment for MR tomography
- 03.28
Urgent Field Safety Notice for Geistlich Bio-Oss Pen by Geistlich Pharma AG
Non-active implants – materials for implants
- 03.28
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
- 03.28
Urgent Field Safety Notice for Cios Spin by Siemens Healthcare GmbH, X-Ray Products (XP)
Radiological technology – mobile radiological diagnostic facilities
- 03.28
Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda)
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
- 03.28
Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP)
Radiological technology – mobile radiological diagnostic facilities
- 03.27
Urgent Field Safety Notice for BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM by Invacare Deutschland GmbH
Orthopaedic / Rehabilitation technology – mobility aids
- 03.27
Urgent Field Safety Notice for S. AIA-PACK Homocysteine by Tosoh Corporation
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.27
Urgent Field Safety Notice for cobas 8000 by Hitachi High-Technologies Corporation
In-vitro diagnostics – equipment / products for clinical chemistry
- 03.27
Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC
In-vitro diagnostics – microbiological products
- 03.27
Urgent Field Safety Notice for MAJ-209 SINGLE USE SUCTION VALVE by Olympus Medical Systems Corp.
Optics / Precision engineering – endoscopes
- 03.27
Urgent Field Safety Notice for S. AIA-PACK ACTH by Tosoh Corporation
In-vitro diagnostics – immunological products
- 03.26
Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC
Active implantable medical devices – cardiac pacemakers
- 03.29
Urgent Field Safety Notice for Ventrikelkatheter by Christoph Miethke GmbH & CoKG
Non-active implants – special implants
- 03.29
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
- 03.29
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
- 03.29
Urgent Field Safety Notice for MRIdian Linac System by ViewRay Inc.
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
- 03.29
Urgent Field Safety Notice for Bohrloch Reservoir Set by Christoph Miethke GmbH & Co. KG
Non-active implants – special implants
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