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

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  • 01.07

Urgent Field Safety Notice for Mayfield Skull Clamp by IntegraLifeSciences Mayfield

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 01.07

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

Physical therapy – hydrotherapy

PDF125KB

  • 01.07

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

Optics / Precision engineering – endoscopes

PDF519KB

  • 01.07

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

Dental products – others

PDF140KB

  • 01.07

Urgent Field Safety Notice for Eye Station by Merge Healthcare

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

PDF55KB

  • 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

PDF89KB

  • 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

PDF171KB

  • 01.07

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

Non-active implants – special implants

PDF30KB

  • 01.10

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF128KB

  • 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

PDF145KB

  • 01.09

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

Non-active implants – bone surgery

PDF268KB

  • 01.09

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

Non-active implants – special implants

PDF101KB

  • 01.08

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

Dental products – equipment

PDF9KB

  • 01.08

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

Dental products – dental implants

PDF201KB

  • 01.08

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

Dental products – dental material

PDF3MB

  • 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

PDF1MB

  • 01.08

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

Medical electronics / Electromedical devices – electrotherapy

PDF65KB

  • 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

PDF2MB

  • 01.07

Urgent Field Safety Notice for Mobi-C by LDR MEDICAL

Non-active implants – bone surgery

PDF445KB

  • 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

PDF412KB

  • 01.07

Urgent Field Safety Notice for Minstrel by ArjoHuntleigh AB

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

PDF355KB

  • 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

PDF499KB

  • 01.07

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

Radiotherapy / Radiation protection – nuclear medical therapeutic equipment

PDF87KB

  • 01.10

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

In-vitro diagnostics – immunological products

PDF682KB

  • 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

PDF100KB

  • 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

PDF367KB

  • 01.10

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF52KB

  • 01.10

Urgent Field Safety Notice for Various by Abbott Ireland Diagnostics Division

In-vitro diagnostics – immunological products

PDF183KB

  • 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

PDF480KB

  • 01.10

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF3MB

  • 01.10

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

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF638KB

  • 01.10

Urgent Field Safety Notice for CLEAN by Roche Diagnostics GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

PDF488KB

  • 01.10

Urgent Field Safety Notice for HeartMate 3 by Thoratec Corporation

Active implantable medical devices – artificial hearts

PDF25KB

  • 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

PDF171KB

  • 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

PDF544KB

  • 01.10

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF210KB

  • 01.10

Urgent Field Safety Notice for STACLOT LA by Stago

In-vitro diagnostics – haematological, histological and cytological products

PDF52KB

  • 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

PDF318KB

  • 01.18

Urgent Field Safety Notice for ECLIPSE 2L by BALT Extrusion

Injections / Infusions / Transfusions / Dialysis – catheters

PDF312KB

  • 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)

PDF1MB

  • 01.17

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

Optics / Precision engineering – endoscopes

PDF185KB

  • 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

PDF354KB

  • 01.16

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF91KB

  • 01.16

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

Medical instruments for use in humans – bone surgery

PDF4MB

  • 01.16

Urgent Field Safety Notice for Vectris by Medtronic Inc

Active implantable medical devices – biostimulators

PDF73KB

  • 01.14

Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare

Medical electronics / Electromedical devices – electrotherapy

PDF1,023KB

  • 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

PDF444KB

  • 01.14

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

Radiological technology – radiological equipment for mammographic diagnostics

PDF382KB

  • 01.14

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF143KB

  • 01.11

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

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF106KB

  • 01.11

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

Medical electronics / Electromedical devices – electrotherapy

PDF226KB

  • 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

PDF115KB

  • 01.11

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

Injections / Infusions / Transfusions / Dialysis – injection kits

PDF59KB

  • 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

PDF192KB

  • 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

PDF84KB

  • 01.23

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

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF2MB

  • 01.23

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

Optics / Precision engineering – endoscopes

PDF2MB

  • 01.23

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

Non-active implants – other implants

PDF1MB

  • 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

PDF92KB

  • 01.23

Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah

Injections / Infusions / Transfusions / Dialysis – catheters

PDF661KB

  • 01.23

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF151KB

  • 01.23

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

Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures

PDF75KB

  • 01.22

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

Contraception – intrauterine device

PDF3MB

  • 01.22

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF68KB

  • 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

PDF26KB

  • 01.22

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF86KB

  • 01.22

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

Non-active implants – special implants

PDF30KB

  • 01.22

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

Radiological technology – CT scanners

PDF3MB

  • 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

PDF248KB

  • 01.31

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

In-vitro diagnostics – instruments, apparatuses and systems

PDF1MB

  • 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

PDF312KB

  • 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

PDF1MB

  • 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

PDF2MB

  • 01.30

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

Radiological technology – stationary radiological equipment

PDF121KB

  • 01.30

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF242KB

  • 01.29

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF152KB

  • 01.29

Urgent Field Safety Notice for Fitbone TAA by Wittenstein intens GmbH

Active implantable medical devices – others

PDF70KB

  • 01.29

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF85KB

  • 01.29

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF613KB

  • 01.29

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

Non-active implants – special implants

PDF162KB

  • 01.25

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF484KB

  • 01.24

Urgent Field Safety Notice for Acusnare Polypectomy Snares by Cook Endoscopy

Optics / Precision engineering – endoscopes

PDF100KB

  • 01.24

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

Active implantable medical devices – defibrillators

PDF279KB

  • 02.05

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

Ultrasonics – ultrasonic diagnostic equipment

PDF280KB

  • 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

PDF8MB

  • 02.05

Urgent Field Safety Notice for AXIUS Blower Mister by Maquet Cardiovascular

Optics / Precision engineering – endoscopes

PDF88KB

  • 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

PDF552KB

  • 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

PDF162KB

  • 02.01

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

Non-active implants – special implants

PDF29KB

  • 02.01

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

Non-active implants – bone surgery

PDF59KB

  • 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

PDF136KB

  • 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

PDF127KB

  • 01.31

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

In-vitro diagnostics – haematological, histological and cytological products

PDF332KB

  • 01.31

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF447KB

  • 01.31

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF64KB

  • 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

PDF347KB

  • 01.31

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

In-vitro diagnostics – immunological products

PDF225KB

  • 01.31

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

In-vitro diagnostics – microbiological products

PDF256KB

  • 02.13

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

Medical data processing (software) – others

PDF182KB

  • 02.12

Urgent Field Safety Notice for SAPPHIRE administration Sets by ICU Medical

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF389KB

  • 02.12

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

ophthalmological technology – equipment for ophthalmological diagnostics

PDF2MB

  • 02.12

Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy

Non-active implants – special implants

PDF2MB

  • 02.12

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

Radiological technology – stationary radiological equipment

PDF69KB

  • 02.12

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

Radiological technology – stationary radiological equipment

PDF69KB

  • 02.11

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF320KB

  • 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

PDF288KB

  • 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)

PDF57KB

  • 02.08

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

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF86KB

  • 02.08

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

Active implantable medical devices – cardiac pacemakers

PDF599KB

  • 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

PDF170KB

  • 02.06

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

Medical electronics / Electromedical devices – electrotherapy

PDF91KB

  • 02.06

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

Non-active implants – materials for implants

PDF113KB

  • 02.06

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

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF309KB

  • 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

PDF1MB

  • 02.20

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF146KB

  • 02.20

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

Non-active implants – bone surgery

PDF79KB

  • 02.19

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

Medical electronics / Electromedical devices – electrotherapy

PDF804KB

  • 02.19

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

Medical electronics / Electromedical devices – electrotherapy

PDF126KB

  • 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

PDF1MB

  • 02.15

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

Dental products – dental implants

PDF401KB

  • 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

PDF4MB

  • 02.14

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF207KB

  • 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

PDF352KB

  • 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

PDF2MB

  • 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

PDF3MB

  • 02.21

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF3MB

  • 02.21

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

Dental products – dental material

PDF119KB

  • 02.21

Urgent Field Safety Notice for Calcium CA3871 by Randox Laboratories Ltd

In-vitro diagnostics – equipment / products for clinical chemistry

PDF1MB

  • 02.21

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

In-vitro diagnostics – microbiological products

PDF210KB

  • 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

PDF2MB

  • 02.21

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

In-vitro diagnostics – haematological, histological and cytological products

PDF359KB

  • 02.21

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

In-vitro diagnostics – instruments, apparatuses and systems

PDF126KB

  • 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

PDF58KB

  • 02.21

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

In-vitro diagnostics – instruments, apparatuses and systems

PDF107KB

  • 02.21

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

In-vitro diagnostics – microbiological products

PDF910KB

  • 02.21

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

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF90KB

  • 02.21

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

In-vitro diagnostics – immunological products

PDF130KB

  • 02.21

Urgent Field Safety Notice for Xpert GBS by Cepheid

In-vitro diagnostics – microbiological products

PDF1MB

  • 02.21

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 02.20

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

Injections / Infusions / Transfusions / Dialysis – infusion technology

PDF2MB

  • 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

PDF584KB

  • 02.26

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

Non-active implants – special implants

PDF1MB

  • 02.26

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

Injections / Infusions / Transfusions / Dialysis – dialysis technology

PDF42KB

  • 02.26

Urgent Field Safety Notice for TULIPS by Ardo medical AG

General equipment for medical treatment – others

PDF189KB

  • 02.26

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

Radiological technology – navigation systems

PDF304KB

  • 02.25

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

Dressings / Pads – others

PDF145KB

  • 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

PDF4MB

  • 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

PDF121KB

  • 02.21

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

In-vitro diagnostics – microbiological products

PDF209KB

  • 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

PDF123KB

  • 02.21

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF660KB

  • 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

PDF385KB

  • 02.21

Urgent Field Safety Notice for DHEA ELISA by IBL International GmbH

In-vitro diagnostics – immunological products

PDF151KB

  • 02.21

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

In-vitro diagnostics – haematological, histological and cytological products

PDF151KB

  • 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

PDF4MB

  • 03.07

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF58KB

  • 03.06

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

In-vitro diagnostics – immunological products

PDF2MB

  • 03.06

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

In-vitro diagnostics – microbiological products

PDF5MB

  • 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

PDF56KB

  • 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

PDF534KB

  • 03.06

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

In-vitro diagnostics – immunological products

PDF573KB

  • 03.06

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

In-vitro diagnostics – microbiological products

PDF200KB

  • 03.06

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

In-vitro diagnostics – instruments, apparatuses and systems

PDF339KB

  • 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

PDF329KB

  • 02.28

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF2MB

  • 02.27

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

General equipment for medical treatment – cleaning / disinfection / sterilisation

PDF6MB

  • 02.27

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

Medical instruments for use in humans – general instruments

PDF87KB

  • 02.27

Urgent Field Safety Notice for LifePearl microspheres by MicroVention Europe

Non-active implants – special implants

PDF2MB

  • 02.27

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

Medical electronics / Electromedical devices – electrotherapy

PDF177KB

  • 02.26

Urgent Field Safety Notice for Hamilton G5 by Hamilton Medical AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF116KB

  • 03.15

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

In-vitro diagnostics – haematological, histological and cytological products

PDF113KB

  • 03.14

Urgent Field Safety Notice for Reaxon Direct by Medovent GmbH

Non-active implants – other implants

PDF2MB

  • 03.14

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

Ultrasonics – ultrasonic diagnostic equipment

PDF174KB

  • 03.14

Urgent Field Safety Notice for Cannula needle by Applimed SA

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

PDF96KB

  • 03.14

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

Active implantable medical devices – artificial hearts

PDF147KB

  • 03.14

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

Surgical equipment/ Anaesthesia – surgical equipment

PDF54KB

  • 03.14

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF104KB

  • 03.14

Urgent Field Safety Notice for DIPHOTERINE – PREVIN by PREVOR

Physical therapy – insufflation technique

PDF253KB

  • 03.14

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

Active implantable medical devices – artificial hearts

PDF155KB

  • 03.14

Urgent Field Safety Notice for LactoSorb RapidFlap by Biomet Orthopaedic LLC

Non-active implants – bone surgery

PDF212KB

  • 03.14

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

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF78KB

  • 03.11

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

Ultrasonics – ultrasonic diagnostic equipment

PDF174KB

  • 03.11

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF217KB

  • 03.08

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

Non-active implants – bone surgery

PDF33KB

  • 03.08

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

Injections / Infusions / Transfusions / Dialysis – filters

PDF44KB

  • 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

PDF299KB

  • 03.19

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF71KB

  • 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

PDF257KB

  • 03.18

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

Radiological technology – stationary radiological equipment

PDF373KB

  • 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

PDF91KB

  • 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

PDF347KB

  • 03.18

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF268KB

  • 03.15

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

In-vitro diagnostics – microbiological products

PDF198KB

  • 03.15

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

Medical instruments for use in humans – bone surgery

PDF139KB

  • 03.15

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

Injections / Infusions / Transfusions / Dialysis – catheters

PDF4MB

  • 03.15

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF2MB

  • 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.

PDF289KB

  • 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

PDF160KB

  • 03.15

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

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF173KB

  • 03.15

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

In-vitro diagnostics – microbiological products

PDF159KB

  • 03.26

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

Ultrasonics – ultrasonic therapeutic equipment

PDF637KB

  • 03.25

Urgent Field Safety Notice for ARIES products by Luminex Corporation

In-vitro diagnostics – microbiological products

PDF4MB

  • 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

PDF251KB

  • 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

PDF275KB

  • 03.25

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

In-vitro diagnostics – microbiological products

PDF484KB

  • 03.25

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

In-vitro diagnostics – immunological products

PDF806KB

  • 03.25

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

In-vitro diagnostics – microbiological products

PDF2MB

  • 03.25

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF69KB

  • 03.22

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

Non-active implants – special implants

PDF51KB

  • 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

PDF97KB

  • 03.21

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

Radiological technology – mobile radiological diagnostic facilities

PDF1MB

  • 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

PDF388KB

  • 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

PDF276KB

  • 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

PDF695KB

  • 03.20

Urgent Field Safety Notice for CLEO by Hoggi GmbH

Orthopaedic / Rehabilitation technology – mobility aids

PDF565KB

  • 03.28

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

Medical electronics / Electromedical devices – electrodiagnostics

PDF3MB

  • 03.28

Urgent Field Safety Notice for RT Elements by Brainlab AG

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

PDF409KB

  • 03.28

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

Electromedical fields – equipment for MR tomography

PDF118KB

  • 03.28

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

Non-active implants – materials for implants

PDF110KB

  • 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

PDF401KB

  • 03.28

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

Radiological technology – mobile radiological diagnostic facilities

PDF140KB

  • 03.28

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

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

PDF199KB

  • 03.28

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

Radiological technology – mobile radiological diagnostic facilities

PDF168KB

  • 03.27

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

Orthopaedic / Rehabilitation technology – mobility aids

PDF162KB

  • 03.27

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF243KB

  • 03.27

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

In-vitro diagnostics – equipment / products for clinical chemistry

PDF494KB

  • 03.27

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

In-vitro diagnostics – microbiological products

PDF483KB

  • 03.27

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

Optics / Precision engineering – endoscopes

PDF216KB

  • 03.27

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

In-vitro diagnostics – immunological products

PDF243KB

  • 03.26

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

Active implantable medical devices – cardiac pacemakers

PDF2MB

  • 03.29

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

Non-active implants – special implants

PDF2MB

  • 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

PDF173KB

  • 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

PDF1MB

  • 03.29

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

Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy

PDF9MB

  • 03.29

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

Non-active implants – special implants

PDF2MB

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