Людям із порушенням зору 
In English Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2018 – 30.09.2018
Опубліковано 08.10.2018 о 11:54Німеччина
https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724
2018.07.05
Urgent Field Safety Notice for Volista by MAQUET SAS
Surgical equipment/ Anaesthesia – surgical equipment
2018.07.04
Optics / Precision engineering – endoscopes
2018.07.04
Urgent Field Safety Notice for Patientenlifter Carlo by Beka Hospitec GmbH
General equipment for medical treatment – ward equipment and equipment for emergency medical services
2018.07.04
Urgent Field Safety Notice for Palacos und Copal Knochenzemente by Heraeus Medical GmbH
Non-active implants – materials for implants
2018.07.03
Urgent Field Safety Notice for Hydraulic Ureter Dilators by Teleflex Medical
Injections / Infusions / Transfusions / Dialysis – catheters
2018.07.03
Urgent Field Safety Notice for End Ball by Laboratoire ENDALIS
Non-active implants – special implants
2018.07.03
Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme
Physical therapy – massage / mobility devices
2018.07.02
Urgent Field Safety Notice for SQUALE by Orthopaedic & Spine Development
Non-active implants – bone surgery
2018.07.13
Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.13
Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc. Tarrytown
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.12
Urgent Field Safety Notice for M1 Ambulance Co. by Stryker Medical-Kalamazoo
General equipment for medical treatment – ward equipment and equipment for emergency medical services
2018.07.11
Urgent Field Safety Notice for EMU40 by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
Medical electronics / Electromedical devices – electrodiagnostics
2018.07.11
Surgical equipment/ Anaesthesia – surgical equipment
2018.07.11
Urgent Field Safety Notice for SAFIL & NOVOSYN by B. Braun Surgical S.A.
Dressings / Pads – surgical sutures, vascular loops etc.
2018.07.10
Urgent Field Safety Notice for FUJIFILM Flexible Duodenoscope by FUJIFILM Corporation
Optics / Precision engineering – endoscopes
2018.07.10
Urgent Field Safety Notice for OrthoScan Mini C-Arm X-Ray System by OrthoScan, Inc.
Radiological technology – mobile radiological diagnostic facilities
2018.07.09
Urgent Field Safety Notice for Patient Support by Philips Medical Systems DMC GmbH
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
2018.07.09
Urgent Field Safety Notice for VISIONAIRE LIGHTWEIGHT ALIGNMENT ROD by Smith & Nephew, Inc.,
Medical instruments for use in humans – bone surgery
2018.07.09
Urgent Field Safety Notice for MATRIX DS by XION GmbH
Optics / Precision engineering – endoscopes
2018.07.09
Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed
Medical data processing (software) – others
2018.07.06
Urgent Field Safety Notice for Leksell GammaPlan by Elekta Instrument AB
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
2018.07.06
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.07.05
Urgent Field Safety Notice for ProteusPLUS by IBA (Ion Beam Applications)
Radiotherapy / Radiation protection – nuclear medical therapeutic equipment
2018.07.16
Urgent Field Safety Notice for Atellica COAG 360 by Siemens Healthcare Diagnostics Products GmbH
In-vitro diagnostics – haematological, histological and cytological products
2018.07.13
Urgent Field Safety Notice for BacT/ALERT VIRTUO Microbial Detection System by bioMérieux Inc
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.13
Urgent Field Safety Notice for LCD Power supply (LPS) by NordicNeuroLab AS
Electromedical fields – equipment for MR tomography
2018.07.13
In-vitro diagnostics – microbiological products
2018.07.13
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.13
Medical instruments for use in humans – general instruments
2018.07.13
Urgent Field Safety Notice for MagNA Pure 24 System by Roche Diagnostics GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.13
Urgent Field Safety Notice for QMS Teicoplanin Calibrator by Microgenics Corporation
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.13
In-vitro diagnostics – immunological products
2018.07.13
Urgent Field Safety Notice for Monoclonal Mouse Anti-Human MSH2 FE11 by Dako North America, Inc.
In-vitro diagnostics – microbiological products
2018.07.13
Urgent Field Safety Notice for Perifix Catheter Connector by B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.07.13
Urgent Field Safety Notice for LeadcareII/Leadcare Plus by Magellan Diagnostics Inc.
In-vitro diagnostics – haematological, histological and cytological products
2018.07.13
Medical instruments for use in humans – general instruments
2018.07.13
In-vitro diagnostics – immunological products
2018.07.13
Urgent Field Safety Notice for Mullkompressen 5 x 5 cm by Meditrade GmbH
Dressings / Pads – dressings
2018.07.23
Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS
Medical electronics / Electromedical devices – electrotherapy
2018.07.23
Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
2018.07.23
Medical electronics / Electromedical devices – electrotherapy
2018.07.20
Injections / Infusions / Transfusions / Dialysis – catheters
2018.07.20
Urgent Field Safety Notice for DEMOTEK Solution Administration IV set by Demophorius Healthcare LTD
Injections / Infusions / Transfusions / Dialysis – transfusion kits
2018.07.19
Urgent Field Safety Notice for PLATINIUM by MicroPort CRM S.r.l.
Active implantable medical devices – defibrillators
2018.07.18
Urgent Field Safety Notice for VisualaseT Thermal Therapy System by Medtronic Navigation Inc.
Optics / Precision engineering – laser technology
2018.07.18
Urgent Field Safety Notice for Dermatome AN by Zimmer Orthopaedic Surgical Products
Surgical equipment/ Anaesthesia – surgical equipment
2018.07.17
Urgent Field Safety Notice for Jelonet 15x 2 cm Paraffingazeverband by Smith & Nephew Medical Ltd.
Dressings / Pads – dressings
2018.07.17
Urgent Field Safety Notice for COPAL knee moulds by Heraeus Medical GmbH
Medical instruments for use in humans – bone surgery
2018.07.17
Injections / Infusions / Transfusions / Dialysis – drainages and suction systems
2018.07.16
Urgent Field Safety Notice for Persona Spacer Block Alignment Tower by Biomet Orthopaedic LLC
Medical instruments for use in humans – bone surgery
2018.07.16
Dressings / Pads – surgical sutures, vascular loops etc.
2018.07.16
Medical instruments for use in humans – general instruments
2018.07.16
Urgent Field Safety Notice for OPAT RESERVOIR by Haemonetics Corporation
Injections / Infusions / Transfusions / Dialysis – transfusion kits
2018.07.26
Urgent Field Safety Notice for STA Néoplastine CI 10 and CI Plus 10 by Stago
In-vitro diagnostics – haematological, histological and cytological products
2018.07.26
Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.26
Urgent Field Safety Notice for Xpert C.Difficile BT by Cepheid AB, Solna
In-vitro diagnostics – microbiological products
2018.07.26
Urgent Field Safety Notice for Xpert MTB/RIF Ultra by Cepheid AB, Solna
In-vitro diagnostics – microbiological products
2018.07.26
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.26
Urgent Field Safety Notice for IH-Com Kit Fullversion and IH-Com Kit For Reader by DiaMed GmbH
In-vitro diagnostics – instruments, apparatuses and systems
2018.07.26
In-vitro diagnostics – instruments, apparatuses and systems
2018.07.24
Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme
Physical therapy – massage / mobility devices
2018.07.24
Urgent Field Safety Notice for Monnal T60 by Air Liquide Medical Systems
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.07.24
Physical therapy – massage / mobility devices
2018.07.24
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.07.24
Urgent Field Safety Notice for Hall Small Lithium Battery by ConMed Corporation
Surgical equipment/ Anaesthesia – surgical equipment
2018.07.24
Urgent Field Safety Notice for 5008 CorDiax HD-PAED option by Fresenius Medical Care AG & Co. KGaA
Injections / Infusions / Transfusions / Dialysis – dialysis technology
2018.07.23
Urgent Field Safety Notice for LEDVISION by Surgiris S.A.S.
Surgical equipment/ Anaesthesia – surgical equipment
2018.07.23
2018.08.03
Urgent Field Safety Notice for ENNOVATE ROD PERSUADER by Aesculap AG
Medical instruments for use in humans – bone surgery
2018.08.03
Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC
Non-active implants – bone surgery
2018.07.31
In-vitro diagnostics – immunological products
2018.07.31
Urgent Field Safety Notice for ARTIS Q, ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
Radiological technology – radiological equipment for vascular diagnostics
2018.07.31
Urgent Field Safety Notice for sterile Lochschrauben by aap Implantate AG
Non-active implants – bone surgery
2018.07.31
Urgent Field Safety Notice for Molift 2-poing Sling Bar – all sizes by Etac Supply Gjøvik
General equipment for medical treatment – ward equipment and equipment for emergency medical services
2018.07.30
Urgent Field Safety Notice for ARCHITECT Creatine Kinase by Abbott Laboratories
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.30
In-vitro diagnostics – microbiological products
2018.07.30
Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.30
Urgent Field Safety Notice for Alinity c Creatinine Reagent Kit by Abbott GmbH & Co. KG
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.30
Urgent Field Safety Notice for recomWell Borrelia IgM by Mikrogen GmbH
In-vitro diagnostics – microbiological products
2018.07.27
Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda)
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.07.26
Urgent Field Safety Notice for VIDAS CA 15-3 by bioMérieux S. (Marcy- l’Etoile)
In-vitro diagnostics – immunological products
2018.07.26
Urgent Field Safety Notice for EZ1 Advanced XL by QIAGEN GmbH
In-vitro diagnostics – equipment / products for clinical chemistry
2018.07.26
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.09
Radiological technology – stationary radiological equipment
2018.08.09
Urgent Field Safety Notice for Stellaris Elite Single Port Vitrectomy Cutters by Bausch & Lomb Inc
ophthalmological technology – equipment for ophthalmological therapeutics
2018.08.09
Urgent Field Safety Notice for Rusch Green Lite (MAC 3) by Teleflex Medical Athlone
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
2018.08.09
Urgent Field Safety Notice for M300 by Draeger Medical Systems, Inc
Medical electronics / Electromedical devices – electrodiagnostics
2018.08.08
Urgent Field Safety Notice for Knob Assembly contained in MAYFIELD by Integra LifeSciences Corp
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.08
Urgent Field Safety Notice for TRENDHIP STANDARD CEM.LESS 12/14 SIZE 2 by Groupe Lepine
Non-active implants – bone surgery
2018.08.08
Urgent Field Safety Notice for Zytologiebürste Einweg by FENDO Medizinztechnik e.K.
Medical instruments for use in humans – cardiac/thorax surgery
2018.08.07
Radiological technology – stationary radiological equipment
2018.08.07
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
2018.08.07
Urgent Field Safety Notice for Sonolith i-move by EDAP TMS France S.A.
Ultrasonics – ultrasonic therapeutic equipment
2018.08.07
Urgent Field Safety Notice for MAKO Vizadisc Knee/Hip Procedure Tracking Kit by MAKO Surgical Corp.
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.06
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.06
Urgent Field Safety Notice for MyLab Diverse by Esaote S.p.A.
Ultrasonics – ultrasonic diagnostic equipment
2018.08.06
Optics / Precision engineering – endoscopes
2018.08.06
Urgent Field Safety Notice for LipiVage Harvester w/Cannula by Genesis Biosystems
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.20
Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG
General equipment for medical treatment – cleaning / disinfection / sterilisation
2018.08.20
Urgent Field Safety Notice for Organ Care System (OCS) Heart by TransMedics, Inc.
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.20
Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG
Non-active implants – special implants
2018.08.20
Urgent Field Safety Notice for sterEOS workstation by EOS imaging
Radiological technology – auxiliary equipment and supplies for radiology / nuclear medicine
2018.08.20
Contraception – condoms
2018.08.20
Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG
General equipment for medical treatment – cleaning / disinfection / sterilisation
2018.08.20
Urgent Field Safety Notice for Hemodialysis Products by Medcomp Medical Components, Inc.
Injections / Infusions / Transfusions / Dialysis – catheters
2018.08.20
Urgent Field Safety Notice for BIS Vista and BIS View Monitoring Systems by Covidien llc
Medical electronics / Electromedical devices – electrodiagnostics
2018.08.20
Urgent Field Safety Notice for RYTHMIC EVOLUTION by MICREL MEDICAL DEVICES SA
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.08.20
Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH
Radiological technology – stationary radiological equipment
2018.08.20
Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd.
Medical data processing (software) – others
2018.08.10
Medical electronics / Electromedical devices – electrodiagnostics
2018.08.10
Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AG
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.09
Radiological technology – stationary radiological equipment
2018.08.09
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.08.21
Urgent Field Safety Notice for ARCHITECT EBV VCA IgM Controls by Abbott GmbH & Co.KG
In-vitro diagnostics – microbiological products
2018.08.21
Urgent Field Safety Notice for Minicon Clinical Sample Concentrators by Merck Millipore Ltd
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.21
Urgent Field Safety Notice for cobas m 511 integrated hematology analyzer by Roche Diagnostics GmbH
In-vitro diagnostics – haematological, histological and cytological products
2018.08.21
In-vitro diagnostics – haematological, histological and cytological products
2018.08.21
Urgent Field Safety Notice for Oxoid CT0159B by Remel Europe. Part of Thermo Fisher Scientific
In-vitro diagnostics – microbiological products
2018.08.21
Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG
Non-active implants – special implants
2018.08.21
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.08.21
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.20
Urgent Field Safety Notice for AIRO Mobile CT System by Mobius Imaging, LLC
Radiological technology – CT scanners
2018.08.20
Urgent Field Safety Notice for ZNN TIBIAL NAIL by Zimmer Biomet, Inc. Warsaw
Non-active implants – bone surgery
2018.08.20
Urgent Field Safety Notice for MiniMed remote controller by Medtronic Minimed
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.08.20
Radiological technology – radiological equipment for vascular diagnostics
2018.08.20
Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V.
Radiological technology – stationary radiological equipment
2018.08.20
Urgent Field Safety Notice for ECO Bath by CareNow Medical Pvt. Ltd.
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.20
Medical instruments for use in humans – cardiac/thorax surgery
2018.08.23
Urgent Field Safety Notice for BE-HLS 7050#HLS Set Advanced 7.0 by Maquet Cardiopulmonary AG
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.23
Urgent Field Safety Notice for AMSCO V-PRO 1, V-PRO 1 Plus, VPRO maX by Steris Corporation
General equipment for medical treatment – cleaning / disinfection / sterilisation
2018.08.22
Urgent Field Safety Notice for Cannulated Screw-sterile Lochschrauben by aap Implantate AG
Non-active implants – bone surgery
2018.08.22
Urgent Field Safety Notice for Varilymph 12 Pro by SLK Vertriebsgesellschaft mbH
Physical therapy – massage / mobility devices
2018.08.22
Urgent Field Safety Notice for Cardioband by Edwards Cardioband
Non-active implants – cardiac surgery
2018.08.22
Urgent Field Safety Notice for Hiploc Plate by Biomet UK Ltd
Non-active implants – bone surgery
2018.08.22
Urgent Field Safety Notice for DORO LUCENT Base Unit by PMI pro med Instruments GmbH
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.22
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.22
Medical electronics / Electromedical devices – ENT equipment
2018.08.21
Urgent Field Safety Notice for AST-P640 Test Kit and AST-P655 Test Kit by bioMérieux Inc
In-vitro diagnostics – microbiological products
2018.08.21
Medical instruments for use in humans – general instruments
2018.08.21
Urgent Field Safety Notice for Rotating IV pole by GE Healthcare Clinical Systems (Ohmeda Medical)
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.08.21
Urgent Field Safety Notice for Drill CS 2.7/3.5, ø2.7, L 130, quick coupling by aap Implantate AG
Medical instruments for use in humans – bone surgery
2018.08.21
Urgent Field Safety Notice for Output Unit by Hitachi, Ltd.
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.21
Urgent Field Safety Notice for UniCel DxH 800/600 Cellular Analysis Systems by Beckman Coulter, Inc.
In-vitro diagnostics – haematological, histological and cytological products
2018.08.31
Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.30
Medical electronics / Electromedical devices – electrotherapy
2018.08.30
Injections / Infusions / Transfusions / Dialysis – catheters
2018.08.29
Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH
In-vitro diagnostics – microbiological products
2018.08.29
Urgent Field Safety Notice for T.E.S.S Glenoid Drill 5mm by Biomet France SARL
Medical instruments for use in humans – bone surgery
2018.08.29
Urgent Field Safety Notice for Grip Strapper by Liko AB
General equipment for medical treatment – ward equipment and equipment for emergency medical services
2018.08.29
Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH
In-vitro diagnostics – immunological products
2018.08.29
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.29
Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS
Non-active implants – special implants
2018.08.29
Urgent Field Safety Notice for VITROS 5600 Integrated System by Ortho-Clinical Diagnostics, Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.24
Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc
Non-active implants – bone surgery
2018.08.24
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.24
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
2018.08.23
Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME)
Radiological technology – stationary radiological equipment
2018.08.23
Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC
Non-active implants – bone surgery
2018.08.31
Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.30
Medical electronics / Electromedical devices – electrotherapy
2018.08.30
Injections / Infusions / Transfusions / Dialysis – catheters
2018.08.29
Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH
In-vitro diagnostics – microbiological products
2018.08.29
Urgent Field Safety Notice for T.E.S.S Glenoid Drill 5mm by Biomet France SARL
Medical instruments for use in humans – bone surgery
2018.08.29
Urgent Field Safety Notice for Grip Strapper by Liko AB
General equipment for medical treatment – ward equipment and equipment for emergency medical services
2018.08.29
Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH
In-vitro diagnostics – immunological products
2018.08.29
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.29
Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS
Non-active implants – special implants
2018.08.29
Urgent Field Safety Notice for VITROS 5600 Integrated System by Ortho-Clinical Diagnostics, Inc.
In-vitro diagnostics – equipment / products for clinical chemistry
2018.08.24
Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc
Non-active implants – bone surgery
2018.08.24
Surgical equipment/ Anaesthesia – surgical equipment
2018.08.24
Radiotherapy / Radiation protection – radiation facilites with accelerators for teletherapy
2018.08.23
Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME)
Radiological technology – stationary radiological equipment
2018.08.23
Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC
Non-active implants – bone surgery
2018.09.10
Urgent Field Safety Notice for EEA Circular Stapler with Tri-Staple Technology by Covidien llc
Medical instruments for use in humans – general instruments
2018.09.10
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.10
Urgent Field Safety Notice for Unity Drill Assembly Unit, .021 Green by Coltene/Whaledent, lnc.
Dental products – instruments
2018.09.06
Urgent Field Safety Notice for Various brand of IV catheter by Mediplus (India) Linited
Injections / Infusions / Transfusions / Dialysis – catheters
2018.09.06
Urgent Field Safety Notice for Y-Ventil by Sunny Medical Device (Shenzhen) Co., Ltd.
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.09.05
Urgent Field Safety Notice for s.pump by Medos Medizintechnik AG
Surgical equipment/ Anaesthesia – surgical equipment
2018.09.05
Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems
Medical electronics / Electromedical devices – electrodiagnostics
2018.09.04
Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray Incorporated
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
2018.09.04
Urgent Field Safety Notice for Intrafix SafeSet Standard, 180 cm by B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis – infusion kits
2018.09.04
Urgent Field Safety Notice for AlarisT/ AsenaT CC, GH Syringe Pump by BD Switzerland Sarl
Injections / Infusions / Transfusions / Dialysis – infusion technology
2018.09.04
Urgent Field Safety Notice for AlignRT by VisionRT Ltd
Radiotherapy / Radiation protection – radiotherapy treatment planning systems
2018.09.04
Urgent Field Safety Notice for General Impactor by Stanmore Implants Worldwide Ltd
Medical instruments for use in humans – bone surgery
2018.09.04
Urgent Field Safety Notice for AWC-Additional Working Channel by Ovesco Endoscopy AG
Optics / Precision engineering – endoscopes
2018.09.03
Urgent Field Safety Notice for Leica M525 by Leica Microsystems (Schweiz) AG
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
2018.08.31
Urgent Field Safety Notice for EO-150 Ventilator by EOVE
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.09.13
Active implantable medical devices – cardiac pacemakers
2018.09.13
Urgent Field Safety Notice for Neuro Omega by Alpha Omega Engineering Ltd.
Surgical equipment/ Anaesthesia – surgical equipment
2018.09.12
Optics / Precision engineering – medical microscopes (does not incude laboratory microscopes)
2018.09.11
Urgent Field Safety Notice for Getinge WD15 Claro by Getinge Disinfection AB
General equipment for medical treatment – cleaning / disinfection / sterilisation
2018.09.11
Dental products – dental implants
2018.09.10
Urgent Field Safety Notice for Cannulated tap, 5.5 mm by icotec ag
Medical instruments for use in humans – bone surgery
2018.09.10
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.10
In-vitro diagnostics – immunological products
2018.09.10
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.10
In-vitro diagnostics – others
2018.09.10
Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG
In-vitro diagnostics – haematological, histological and cytological products
2018.09.10
Urgent Field Safety Notice for NOVA FA (POL YRAD PREMIUM CSAP) by SEDECAL S. A.
Radiological technology – stationary radiological equipment
2018.09.10
Urgent Field Safety Notice for Suction Catheters, Gastro-enteral Tubes by ConvaTec Limited Deeside
Surgical equipment/ Anaesthesia – surgical equipment
2018.09.10
Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.10
Urgent Field Safety Notice for cobas e411 by Hitachi High-Technologies, Medical Systems QA Group
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.21
Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc.
Radiological technology – navigation systems
2018.09.20
Urgent Field Safety Notice for Low Volume IV Filter / BC 693 by Bayer Medical Care Inc.
Injections / Infusions / Transfusions / Dialysis – infusion kits
2018.09.20
Urgent Field Safety Notice for Peek Acuity Pro by Peek Vision Ltd
Medical data processing (software) – facet_09md-07
2018.09.20
Urgent Field Safety Notice for AFX EndoVascular AAA System by Endologix, Inc.
Non-active implants – special implants
2018.09.20
Urgent Field Safety Notice for Diverse Dentalimplantate by VICTORY
Dental products – dental implants
2018.09.18
Urgent Field Safety Notice for Lone Star Single-Use Elastic Stays by Cooper Surgical Inc.
Medical instruments for use in humans – visceral surgery
2018.09.17
In-vitro diagnostics – microbiological products
2018.09.17
Urgent Field Safety Notice for Alere DDS2 Test Kit by Alere Toxicology Plc
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.17
Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.17
Urgent Field Safety Notice for Aptio Automation by Inpeco SA
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.17
Urgent Field Safety Notice for ALTRIX, 220-240V/50HZ, TYPE F by Stryker Medical-Kalamazoo
Surgical equipment/ Anaesthesia – surgical equipment
2018.09.17
Urgent Field Safety Notice for Alere Triage NT-proBNP Test by Alere San Diego, Inc.
In-vitro diagnostics – immunological products
2018.09.17
Urgent Field Safety Notice for CARESCAPE Monitor B650 by GE Healthcare Finland Oy
Medical electronics / Electromedical devices – electrodiagnostics
2018.09.13
Urgent Field Safety Notice for Powerflex PRO PTA balloon dilation by Cordis Corporation
Injections / Infusions / Transfusions / Dialysis – catheters
2018.09.13
Urgent Field Safety Notice for LATITUDE Programmer by Boston Scientific CRM
Active implantable medical devices – cardiac pacemakers
2018.09.25
Urgent Field Safety Notice for FlexLab by Inpeco SA
In-vitro diagnostics – instruments, apparatuses and systems
2018.09.25
Urgent Field Safety Notice for Single-Use, Colpo-Pneumo Occluder by Cooper Surgical Inc.
Medical instruments for use in humans – gynaecology
2018.09.25
In-vitro diagnostics – microbiological products
2018.09.25
Urgent Field Safety Notice for Alinity i Processing Module by Abbott GmbH & Co. KG
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.25
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.25
General equipment for medical treatment – furnishings
2018.09.25
Urgent Field Safety Notice for Pastorex Meningitis by Bio-Rad Laboratories France
In-vitro diagnostics – microbiological products
2018.09.25
Urgent Field Safety Notice for Kaluza C Software version 1.0 by Beckman Coulter, Inc.
In-vitro diagnostics – haematological, histological and cytological products
2018.09.25
Urgent Field Safety Notice for PATHFAST by LSI Medience Corporation
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.25
Non-active implants – bone surgery
2018.09.25
In-vitro diagnostics – equipment / products for clinical chemistry
2018.09.24
Urgent Field Safety Notice for BD Micro-Fine Ultra by Becton Dickinson Franklin Lakes
Injections / Infusions / Transfusions / Dialysis – insulin pens and pen cannulas
2018.09.21
Urgent Field Safety Notice for KURZ-Precise Schneideblock by Heinz Kurz GmbH Medizintechnik
Medical instruments for use in humans – bone surgery
2018.09.21
Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
Active implantable medical devices – artificial hearts
2018.09.21
Urgent Field Safety Notice for CentriMag Blood Pumping System by Thoratec Corporation
Surgical equipment/ Anaesthesia – surgical equipment
2018.09.26
Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply
2018.09.26
Urgent Field Safety Notice for 220-240V Unit Cable (power cord) by B. Braun Melsungen AG
Injections / Infusions / Transfusions / Dialysis – infusion technology
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