Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2018 – 29.12.2018

Опубліковано 08.01.2019 о 10:27

Німеччина

https://www.bfarm.de/SiteGlobals/Forms/Suche/EN/kundeninfo_Filtersuche_Formular_en.html?nn=4527724

 

 

  • 10.02

Urgent Field Safety Notice for Millennium MG, Millennium MC, Millennium MYOSIG by GE Medical Systems Israel, Functional Imaging

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

  • 10.02

Urgent Field Safety Notice for BRONCHOSKOP-TUBUS by Richard Wolf GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 10.02

Urgent Field Safety Notice for DrillSaw Sports 400 System Li-Ion Battery Housing by Arthrex INC

Surgical equipment/ Anaesthesia – surgical equipment

  • 10.02

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

Injections / Infusions / Transfusions / Dialysis – catheters

  • 10.02

Urgent Field Safety Notice for Silk+ by BALT Extrusion

Non-active implants – special implants

  • 10.02

Urgent Field Safety Notice for DRILL BIT by Orthofix SRL

Medical instruments for use in humans – bone surgery

  • 10.01

Urgent Field Safety Notice for HydroSet Injectable HA Bone Substitute by Stryker Leibinger GmbH & Co. KG

Non-active implants – materials for implants

  • 10.01

Urgent Field Safety Notice for Impella 2.5 Herzpumpe, Impella CP Herzpumpe by Abiomed Europe GmbH

Medical electronics / Electromedical devices – electrotherapy

  • 10.01

Urgent Field Safety Notice for Activa PC Neurostimulator, Activa S.Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator by Medtronic Inc

Active implantable medical devices – biostimulators

 

  • 10.09

Urgent Field Safety Notice for Biograph Horizon and Biograph mCT by Siemens Medical Solutions USA, Inc. Molecular Imaging

Radiological technology – CT scanners

  • 10.08

Urgent Field Safety Notice for fabian Therapy evolution by Acutronic Medical Systems AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 10.08

Urgent Field Safety Notice for GMM Tables starting from serial number 010/313 until serial number 33130 by General Medical Merate S.p.A.

Surgical equipment/ Anaesthesia – surgical equipment

  • 10.08

Urgent Field Safety Notice for StageOne Select, Hip Cement Spacer Molds by Biomet Orthopedics LLC

Non-active implants – materials for implants

  • 10.05

Urgent Field Safety Notice for Artis Zee ceiling by Siemens Healthcare GmbH, X-Ray Products (XP)

Radiological technology – radiological equipment for vascular diagnostics

  • 10.05

Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray Incorporated

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

  • 10.05

Urgent Field Safety Notice for EVIS EXERA DUODENOVIDEOSCOPE PJF-160 by Olympus Winter & Ibe GmbH

Optics / Precision engineering – endoscopes

  • 10.05

Urgent Field Safety Notice for AK 98 by Gambro Lundia AB

Injections / Infusions / Transfusions / Dialysis – dialysis technology

  • 10.05

Urgent Field Safety Notice for Alere TESTPACK + Plus STREP A with OBC by Alere Medical Co., Ltd

In-vitro diagnostics – immunological products

  • 10.05

Urgent Field Safety Notice for CONTAINERS , CRYO BIOLOGICAL STORAGE by Cryo Diffusion

Surgical equipment/ Anaesthesia – surgical equipment

  • 10.05

Urgent Field Safety Notice for H3 Poly Inlay by DT MedTech

Non-active implants – bone surgery

  • 10.04

Urgent Field Safety Notice for Slide Labeler (Zebra) used with BOND-MAX/BOND-III by Leica Biosystems Melbourne Pty Ltd

In-vitro diagnostics – instruments, apparatuses and systems

  • 10.04

Urgent Field Safety Notice for Avantage Acetabular Shell Inserter Instrument by Biomet France SARL

Medical instruments for use in humans – bone surgery

  • 10.04

Urgent Field Safety Notice for Instrument Manager Software by Data Innovations LLC

In-vitro diagnostics – equipment / products for clinical chemistry

  • 10.04

Urgent Field Safety Notice for CyPass System by Alcon Laboratories, Inc.

Non-active implants – other implants

 

  • 10.15

Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC

Non-active implants – bone surgery

  • 10.15

Urgent Field Safety Notice for LifeStream Balloon expandable vascular Covered Stent by ClearStream Technologies Ltd.

Non-active implants – special implants

  • 10.15

Urgent Field Safety Notice for LifeStream Balloon expandable vascular Covered Stent by ClearStream Technologies Ltd.

Non-active implants – special implants

  • 10.15

Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc.

Radiological technology – navigation systems

  • 10.12

Urgent Field Safety Notice for TB Series – Bipolar Pacing Leads by Oscor Inc.

Medical electronics / Electromedical devices – electrotherapy

  • 10.12

Urgent Field Safety Notice for NanoKnife Single Electrode Probe by AngioDynamics Inc. (Manchester USA)

Medical electronics / Electromedical devices – electrotherapy

  • 10.11

Urgent Field Safety Notice for 980 Ventilator, Compressor Configuration, Germany (PB 980) by Covidien llc

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 10.11

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

  • 10.11

Urgent Field Safety Notice for Symbia Evo Excel by Siemens Medical Solutions USA, Inc. Molecular Imaging

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

  • 10.11

Urgent Field Safety Notice for Revision femoral head by Limacorporate S.p.A.

Non-active implants – bone surgery

  • 10.11

Urgent Field Safety Notice for Espiner Tissue Retrieval System by Fannin UK Ltd

Optics / Precision engineering – precision instruments for gastrointestinal and urological endoscopy and hysteroscopy

  • 10.10

Urgent Field Safety Notice for SOPHIE by Fritz Stephan GmbH

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 10.10

Urgent Field Safety Notice for Foley Catheter Temperature Sensor by Smiths Medical ASD, Inc.

Injections / Infusions / Transfusions / Dialysis – catheters

  • 10.10

Urgent Field Safety Notice for Parking brakes for wheelchair Cross by Etac Supply Center AB

Orthopaedic / Rehabilitation technology – mobility aids

  • 10.09

Urgent Field Safety Notice for Inter-atrial Shunt Device (IASD) System II/ Corvia Medical, Inc. by Corvia Medical, Inc.

Non-active implants – cardiac surgery

 

  • 10.22

Urgent Field Safety Notice for Jarvik 2000 Heart JHI-001 by Jarvik Heart Inc.

Active implantable medical devices – artificial hearts

  • 10.22

Urgent Field Safety Notice for Artis zee biplane and Artis Q biplane by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

  • 10.19

Urgent Field Safety Notice for Parietex Comp Stomy by Sofradim (subsidiary of Covidien)

Non-active implants – special implants

  • 10.18

Urgent Field Safety Notice for Medical Air Ensure by Drägerwerk AG & Co. KGaA

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 10.18

Urgent Field Safety Notice for Cera Plug by Lifetech Scientific Co.LTD

Non-active implants – special implants

  • 10.18

Urgent Field Safety Notice for CardioMems Hospital and Patient Electronic System by S.. Jude Medical, Inc. – CardioMEMS

Active implantable medical devices – measuring devices and sensors

  • 10.17

Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope Corp)

Surgical equipment/ Anaesthesia – surgical equipment

  • 10.17

Urgent Field Safety Notice for Mon-a-Therm Foley catheters with temperature sens by Degania Silicone Ltd.

Injections / Infusions / Transfusions / Dialysis – catheters

  • 10.17

Urgent Field Safety Notice for Rapid Flap SpinDown Clamp by Biomet Orthopaedic LLC

Non-active implants – bone surgery

  • 10.16

Urgent Field Safety Notice for GENESIS II MIS DCF DISTAL CUTTING BLOCK by Smith & Nephew, Inc.,

Medical instruments for use in humans – bone surgery

  • 10.15

Urgent Field Safety Notice for BridgeMaster medicalFetal Scalp Blood SamplingKits by BridgeMaster medical Limited

Injections / Infusions / Transfusions / Dialysis – syringes and cannulas

  • 10.15

Urgent Field Safety Notice for Titanbase MyPlant II by Hager & Meisinger GmbH

Dental products – dental implants

  • 10.15

Urgent Field Safety Notice for LifeStream Balloon expandable vascular Covered Stent by ClearStream Technologies Ltd.

Non-active implants – special implants

  • 10.15

Urgent Field Safety Notice for UV-Therapiesystem UV 7001 by Herbert Waldmann GmbH & Co.

Physical therapy – phototherapy

  • 10.15

Urgent Field Safety Notice for Drill, AO Coupling, Ø 3 mm for 13mm screw by icotec ag

Medical instruments for use in humans – bone surgery

 

  • 10.25

Urgent Field Safety Notice for iChem VELOCITY Chemistry Strips by IRIS International

In-vitro diagnostics – equipment / products for clinical chemistry

  • 10.25

Urgent Field Safety Notice for HistoCore Spectra CV by Leica Biosystems Nussloch GmbH

In-vitro diagnostics – instruments, apparatuses and systems

  • 10.25

Urgent Field Safety Notice for Elecsys FT4 III by Roche Diagnostics GmbH

In-vitro diagnostics – immunological products

  • 10.25

Urgent Field Safety Notice for ClinRep UHPLC Komplettkit Antiepileptika by RECIPE Chemicals + Instruments GmbH

In-vitro diagnostics – equipment / products for clinical chemistry

  • 10.25

Urgent Field Safety Notice for compass 530 Haltungs- / Bruststabilisator by Proxomed Medizintechnik GmbH

Physical therapy – massage / mobility devices

  • 10.25

Urgent Field Safety Notice for Dispenser Issues with Hematoxylin II and Horseradish Peroxidase reagents by Ventana Medical Systems, Inc

In-vitro diagnostics – immunological products

  • 10.25

Urgent Field Safety Notice for XL t(3;3) GATA2/MECOM DF by MetaSystems Probes GmbH

In-vitro diagnostics – immunological products

  • 10.25

Urgent Field Safety Notice for ARCHITECT HAVAB-IgG by Abbott GmbH & Co. KG

In-vitro diagnostics – microbiological products

  • 10.25

Urgent Field Safety Notice for Owren’s PT by MediRox AB

In-vitro diagnostics – haematological, histological and cytological products

  • 10.25

Urgent Field Safety Notice for BioGX by BioGX BV

In-vitro diagnostics – microbiological products

  • 10.24

Urgent Field Safety Notice for BARD ePTFE Small Beading Vascular Graft Products by Bard Peripheral Vascular (BPV)

Non-active implants – special implants

  • 10.24

Urgent Field Safety Notice for IV s.t. by ICU Medical Inc.

Injections / Infusions / Transfusions / Dialysis – infusion kits

  • 10.23

Urgent Field Safety Notice for TERMINAL UNIT BM O2 NF by Air Liquide Medical Systems

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 10.23

Urgent Field Safety Notice for THERMOSET Closed-Loop Injectable Delivery system by ICU Medical Inc.

Injections / Infusions / Transfusions / Dialysis – infusion technology

  • 10.22

Urgent Field Safety Notice for Synergy Cranial, StealthStation Cranial by Medtronic Navigation Inc.

Radiological technology – navigation systems

 

  • 10.26

Urgent Field Safety Notice for Mobilisations-Reharollstuhl Thekla by Hanse-Medizintechnik Dipl. Ing. P. Hettmer GmbH

Orthopaedic / Rehabilitation technology – mobility aids

  • 10.25

Urgent Field Safety Notice for BD MAX Instrument 6-channels by Becton, Dickinson and Company

In-vitro diagnostics – instruments, apparatuses and systems

  • 10.25

Urgent Field Safety Notice for VITEK 2 AST-ST01, ST03 by bioMerieux Inc

In-vitro diagnostics – microbiological products

  • 10.25

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

Non-active implants – other implants

  • 10.25

Urgent Field Safety Notice for Jasper Vektor by TP Orthodontics, Inc

Dental products – orthodontic equipment

  • 10.25

Urgent Field Safety Notice for Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module by Abbott GmbH & Co. KG

In-vitro diagnostics – haematological, histological and cytological products

  • 10.25

Urgent Field Safety Notice for Randox Liquid Cardiac Control by Randox Laboratories Ltd

In-vitro diagnostics – immunological products

  • 10.25

Urgent Field Safety Notice for Yersinia enterocolitica IgA ELISA by IBL International GmbH

In-vitro diagnostics – immunological products

  • 10.25

Urgent Field Safety Notice for Shoulder arthroscopy plate for schaerer axis by Schaerer Medical AG

Surgical equipment/ Anaesthesia – surgical equipment

  • 10.25

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

Radiological technology – stationary radiological equipment

  • 10.25

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

In-vitro diagnostics – equipment / products for clinical chemistry

  • 10.25

Urgent Field Safety Notice for QUADROX-i Neonatal Microporous Membrane Oxygenator by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

  • 10.25

Urgent Field Safety Notice for RAPIDPOINT 500 by Siemens Healthcare Diagnostics Inc. Tarrytown

In-vitro diagnostics – equipment / products for clinical chemistry

  • 10.25

Urgent Field Safety Notice for VeriSeq NIPT Solution by Illumina, Inc.

In-vitro diagnostics – instruments, apparatuses and systems

  • 10.25

Urgent Field Safety Notice for Dimension Integrated Chemistry Systems by Siemens Healthcare Diagnostics, Inc

In-vitro diagnostics – equipment / products for clinical chemistry

 

  • 10.31

Urgent Field Safety Notice for S.A. S41 by Guangzhou Sunray Medical Apparatus Co., Ltd.

Medical electronics / Electromedical devices – electrodiagnostics

  • 10.31

Urgent Field Safety Notice for Cervical locking cage + Lumbar locking cage by EUROSPINE SARL

Non-active implants – bone surgery

  • 10.31

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

Surgical equipment/ Anaesthesia – surgical equipment

 

  • 10.31

Urgent Field Safety Notice for Transbronchiale Aspirationsnadel S.by Endo-Flex GmbH

Optics / Precision engineering – endoscopes

  • 10.30

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

Radiological technology – radiological equipment for vascular diagnostics

  • 10.30

Urgent Field Safety Notice for HeartStart FR3 by Philips Healthcare, Bothell

Medical electronics / Electromedical devices – electrotherapy

  • 10.30

Urgent Field Safety Notice for D2RS / DX-D800 / Visionary DRF by Stephanix

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

  • 10.30

Urgent Field Safety Notice for Dash 3000/4000/5000, Solar 8000M/i, Solar 9500 by GE Medical Systems Information Technologies, Inc.

Medical electronics / Electromedical devices – electrodiagnostics

  • 10.30

Urgent Field Safety Notice for Ovation Abdominal Stent Graft System by TriVascular, Inc.

Non-active implants – special implants

  • 10.30

Urgent Field Safety Notice for Carescape B850, B650, B450 by GEHealthcare Finland Oy

Medical electronics / Electromedical devices – electrodiagnostics

  • 10.29

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

Active implantable medical devices – defibrillators

  • 10.29

Urgent Field Safety Notice for Connex.Spot Monitor by Welch Allyn Inc.

Medical electronics / Electromedical devices – electrodiagnostics

  • 10.29

Urgent Field Safety Notice for NOVOSYN VIOLET 3/0(2)4X70CM HR22TO by B. Braun Surgical S.A.

Dressings / Pads – surgical sutures, vascular loops etc.

  • 10.29

Urgent Field Safety Notice for Prodiva1.5T CX and Prodiva1.5T CS by Philips Healthcare (Suzhou) Co.,Ltd

Electromedical fields – equipment for MR tomography

  • 10.29

Urgent Field Safety Notice for CODAN Guard V86, V86-R by CODAN Medizinische Geräte GmbH & Co KG

Injections / Infusions / Transfusions / Dialysis – infusion technology

 

  • 11.12

Urgent Field Safety Notice for PLEX Elite 9000 S.-OCT by Carl Zeiss Meditec, Inc.

ophthalmological technology – equipment for ophthalmological diagnostics

  • 11.09

Urgent Field Safety Notice for Trauma Guide Wire by Zimmer Inc.

Medical instruments for use in humans – bone surgery

  • 11.08

Urgent Field Safety Notice for Aisys, Aisys CS2 by Datex-Ohmeda, Inc.

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 11.08

Urgent Field Safety Notice for Thermablate EAS by Idoman Teoranta

Medical electronics / Electromedical devices – electrotherapy

  • 11.08

Urgent Field Safety Notice for S.-RX Pulse Generator by Boston Scientific CRM

Active implantable medical devices – defibrillators

  • 11.08

Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by GE Healthcare Clinical Systems (Ohmeda Medical)

Physical therapy – climatotherapy

  • 11.08

Urgent Field Safety Notice for Uresta Bladder Support by Southmedic, Inc.

Orthopaedic / Rehabilitation technology – care of natural and artificial body orifices

  • 11.07

Urgent Field Safety Notice for Flexmobil Forma, Miniflex Forma by Eurovema AB

Orthopaedic / Rehabilitation technology – mobility aids

  • 11.07

Urgent Field Safety Notice for Sawblades for bone surgery for single use -STERILE by Gebr. Brasseler GmbH & Co. KG

Medical instruments for use in humans – bone surgery

  • 11.07

Urgent Field Safety Notice for Infinity DBS System (8-Channel) by S.. Jude Medical – Neuromodulation Division

Active implantable medical devices – biostimulators

  • 11.07

Urgent Field Safety Notice for Suction & Irrigation Probe by Mölnlycke Health Care AB

Optics / Precision engineering – endoscopes

  • 11.05

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

Surgical equipment/ Anaesthesia – surgical equipment

  • 11.05

Urgent Field Safety Notice for SP4S, SP4S option AT, SP4S option AP by Stephanix

Radiological technology – stationary radiological equipment

  • 11.05

Urgent Field Safety Notice for Capnostream 20 and Capnostream 20p Bedside Patient Monitors by Oridion Medical 1987 Ltd.

Medical electronics / Electromedical devices – electrodiagnostics

  • 11.05

Urgent Field Safety Notice for Avenir Muller Stem (Std./Lateral) by Zimmer GmbH

Non-active implants – bone surgery

  • 11.21

Urgent Field Safety Notice for Hematek Modified Wright / Wright-Giemsa Stain Pack by Siemens Healthcare Diagnostics Inc.Tarrytown

In-vitro diagnostics – haematological, histological and cytological products

  • 11.21

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

  • 11.21

Urgent Field Safety Notice for NucliSENS Lysis Buffer by bioMérieux S. (Marcy- l’Etoile)

In-vitro diagnostics – microbiological products

  • 11.19

Urgent Field Safety Notice for Brilliance 6 (Air), Brilliance 10 (Air), Brillianc by PHILIPS MEDICAL SYSTEMS (Cleveland), Inc. (CL)

Radiological technology – CT scanners

  • 11.19

Urgent Field Safety Notice for IMRIS Operating Room Tables by Deerfield Imaging, Inc.

Electromedical fields – equipment for MR tomography

  • 11.16

Urgent Field Safety Notice for Minisart by Sartorius Stedim Biotech GmbH

Injections / Infusions / Transfusions / Dialysis – filters

  • 11.16

Urgent Field Safety Notice for Artelac Rebalance EDO /Artelac Rebalance SDU by Dr. Gerhard Mann Chem. Pharm. Fabrik

ophthalmological technology – liquid media for ophthalmological purposes

  • 11.16

Urgent Field Safety Notice for MONT BLANC MIS – Tightening shaft for outer locking screw – Reference : by SPINEWAY

Medical instruments for use in humans – bone surgery

  • 11.15

Urgent Field Safety Notice for Medtronic StrataMR Adjustment Tool Kit by Medtronic Inc

Non-active implants – special implants

  • 11.14

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

Medical electronics / Electromedical devices – electrodiagnostics

  • 11.14

Urgent Field Safety Notice for Uricran-Forte/ Utipro Plus by NOVENTURE SL

Physical therapy – others

  • 11.14

Urgent Field Safety Notice for NOSOCOMIA PREDESINFECTANT INSTRUMENTS by PRODENE KLINT LABORATOIRES

General equipment for medical treatment – cleaning / disinfection / sterilisation

  • 11.13

Urgent Field Safety Notice for L25 Needle Guide Bracket by CIVCO Medical Instruments CO

Medical instruments for use in humans – general instruments

  • 11.13

Urgent Field Safety Notice for KODAK DirectView DR 7500 System by Carestream Health Inc.

Radiological technology – stationary radiological equipment

  • 11.12

Urgent Field Safety Notice for ZCORET Porcine Xenograft Particulate by Collagen Matrix, Inc.

Non-active implants – materials for implants

 

  • 11.21

Urgent Field Safety Notice for Lactate Dehydrogenase Flex reagent cartridge by Siemens Healthcare Diagnostics Inc. Newark

In-vitro diagnostics – equipment / products for clinical chemistry

  • 11.21

Urgent Field Safety Notice for PakAuto by immucor GTI Diagnostics, Inc.

In-vitro diagnostics – microbiological products

  • 11.21

Urgent Field Safety Notice for gabControl, Hitado, DiaTest, IDEAL H. pylori by gabmed GmbH

In-vitro diagnostics – microbiological products

  • 11.21

Urgent Field Safety Notice for FTlyo 2+.1 ; FTlyo2P.3 ; FTlyo 48.1; FTlyo 56.1 by Fast Track Diagnostics Luxembourg S.à.r.l

In-vitro diagnostics – instruments, apparatuses and systems

  • 11.21

Urgent Field Safety Notice for ORG 243M Anti-Annexin V IgM by Orgentec Diagnostika GmbH

In-vitro diagnostics – immunological products

  • 11.21

Urgent Field Safety Notice for NADAL PROM Amniotic fluid Test by nal von minden GmbH

In-vitro diagnostics – immunological products

  • 11.21

Urgent Field Safety Notice for Salus-10-AM-EU by SciCan

General equipment for medical treatment – cleaning / disinfection / sterilisation

  • 11.21

Urgent Field Safety Notice for VITROS 3600, 4600, 5600, 7600 & 5,1FS by Ortho Clinical Diagnostics Inc

In-vitro diagnostics – equipment / products for clinical chemistry

  • 11.21

Urgent Field Safety Notice for Oxoid Brilliance VRE Agar Oxoid Brilliance VRE Agar by Thermo Fisher Scientific Microbiology Basingstoke

In-vitro diagnostics – microbiological products

  • 11.21

Urgent Field Safety Notice for Owren’s PT by MediRox AB

In-vitro diagnostics – haematological, histological and cytological products

  • 11.21

Urgent Field Safety Notice for Human IgM Kit for SPA PLUS – NK012.S by The Binding Site Group Limited

In-vitro diagnostics – microbiological products

  • 11.21

Urgent Field Safety Notice for Androstenedione ELISA by IBL International GmbH

In-vitro diagnostics – immunological products

  • 11.21

Urgent Field Safety Notice for Protexis Neoprene Surgical Glove by Cardinal Health

General equipment for medical treatment – auxiliary equipment

  • 11.21

Urgent Field Safety Notice for Ratiomed H. pylori by megro GmbH& Co. KG

In-vitro diagnostics – microbiological products

  • 11.21

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

In-vitro diagnostics – equipment / products for clinical chemistry

 

  • 11.29

Urgent Field Safety Notice for Curavisc, Hyaluronic Acid 1% by Curasan AG

Non-active implants – materials for implants

  • 11.29

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

Radiological technology – stationary radiological equipment

  • 11.28

Urgent Field Safety Notice for 3Shape X1 by 3Shape Medical

Radiological technology – CT scanners

  • 11.28

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

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 11.28

Urgent Field Safety Notice for Suture Anchor, Nano Corkscrew® FT, Ti, w 3-0 FW by Arthrex Inc.

Non-active implants – bone surgery

  • 11.27

Urgent Field Safety Notice for B20, B40 Patient Monitor B125 / B105 by GE Medical Systems Information Technologies

Medical electronics / Electromedical devices – electrodiagnostics

  • 11.27

Urgent Field Safety Notice for MP-Prothesenschaft, XS-0, L=160 by Waldemar Link GmbH & Co. KG

Non-active implants – bone surgery

  • 11.26

Urgent Field Safety Notice for Inkubator Neonatal Giraffe OmniBed by GE Healthcare Clinical Systems (Ohmeda Medical)

Physical therapy – climatotherapy

  • 11.23

Urgent Field Safety Notice for Offset Head CrCo 50×20;Centered Head CrCo 50×19 by FX Solutions

Non-active implants – bone surgery

  • 11.22

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

Dental products – equipment

  • 11.22

Urgent Field Safety Notice for ACTREEN LITE NELATON by B. Braun Medical SAS

Injections / Infusions / Transfusions / Dialysis – catheters

  • 11.22

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

  • 11.22

Urgent Field Safety Notice for BiMobile Cup C, Liner, UHMWPE by Waldemar Link GmbH & Co. KG

Non-active implants – bone surgery

  • 11.21

Urgent Field Safety Notice for ORG 242G Anti-alpha-Fodrin IgG by Orgentec Diagnostika GmbH

In-vitro diagnostics – immunological products

  • 11.21

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

In-vitro diagnostics – immunological products

  • 12.05

Urgent Field Safety Notice for fabian Therapy evolution / fabian +nCPAP evolution by Acutronic Medical Systems AG

Surgical equipment/ Anaesthesia – anaesthesia and medical gas supply

  • 12.05

Urgent Field Safety Notice for MOSAIQ by IMPAC Medical Systems, Inc.

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

  • 12.05

Urgent Field Safety Notice for Biograph Horizon by Siemens Medical Solutions USA, Inc. Molecular Imaging

Radiological technology – CT scanners

  • 12.04

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

Dental products – dental implants

  • 12.04

Urgent Field Safety Notice for da Vinci Surgical System by Intuitive Surgical, Inc.

Surgical equipment/ Anaesthesia – surgical equipment

  • 12.03

Urgent Field Safety Notice for Procedure Pack by Medline International France SAS

Medical instruments for use in humans – general instruments

  • 12.03

Urgent Field Safety Notice for SENSIS Vibe Combo by Siemens Healthcare GmbH Advanced Therapies

Radiological technology – radiological equipment for vascular diagnostics

  • 12.03

Urgent Field Safety Notice for PNEUMOCLEAR Heizschlauchset High-Flow by W.O.M. World of Medicine AG

Optics / Precision engineering – endoscopes

  • 12.03

Urgent Field Safety Notice for NAUSI-BIRD COMPACT 190, BLUE FLYER COMPACT by Nausicaa Medical S.A.S

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

  • 11.30

Urgent Field Safety Notice for Absaug- und Antikoagulanzleitung by Medtronic Inc

Injections / Infusions / Transfusions / Dialysis – transfusion kits

  • 11.30

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

  • 11.30

Urgent Field Safety Notice for Emprint Percutaneous Antenna -Thermosphere Tech by Covidien LLC

Medical electronics / Electromedical devices – electrotherapy

  • 11.30

Urgent Field Safety Notice for Dualstop by VYGON S.A.

Injections / Infusions / Transfusions / Dialysis – infusion kits

  • 11.30

Urgent Field Safety Notice for CERAMENT|G, CERAMENT|BONEVOID FILLER,CERAMENT|V by BoneSupport AB

Non-active implants – materials for implants

  • 11.29

Urgent Field Safety Notice for FORCEPS, COUPLER GEM4183C by Synovis Micro Companies Alliance, Inc.

Non-active implants – special implants

 

  • 12.18

Urgent Field Safety Notice for CARDIOVIT MS-2010 by Schiller AG

Medical electronics / Electromedical devices – electrodiagnostics

  • 12.18

Urgent Field Safety Notice for Xsense DR by General Medical Merate S.p.A.

Radiological technology – stationary radiological equipment

  • 12.17

Urgent Field Safety Notice for I-View Contrast Enhanced Digital Mammography by Hologic, Inc. (Danbury)

Radiological technology – radiological equipment for mammographic diagnostics

  • 12.14

Urgent Field Safety Notice for Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with by GE Medical Systems, LLC

Electromedical fields – equipment for MR tomography

  • 12.13

Urgent Field Safety Notice for Discovery NM 530c, Ventri by GEMedical Systems Israel, Functional Imaging

Radiological technology – equipment for nuclear medical functional and localisation diagnostics

  • 12.11

Urgent Field Safety Notice for multiFiltrate PRO by Fresenius Medical Care AG & Co. KGaA

Injections / Infusions / Transfusions / Dialysis – dialysis technology

  • 12.11

Urgent Field Safety Notice for AngelSounds JPD-100S4 Fetal Doppler by Jumper Medical Equipment Co. Ltd.

Ultrasonics – ultrasonic diagnostic equipment

  • 12.11

Urgent Field Safety Notice for VisuMax by Carl Zeiss Meditec AG

ophthalmological technology – equipment for ophthalmological therapeutics

  • 12.11

Urgent Field Safety Notice for Diverse Endoscope by Olympus Medical Systems Corp.

Optics / Precision engineering – endoscopes

  • 12.11

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

Radiological technology – stationary radiological equipment

  • 12.11

Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AG

Surgical equipment/ Anaesthesia – surgical equipment

  • 12.10

Urgent Field Safety Notice for Dualstop by VYGON S.A.

Injections / Infusions / Transfusions / Dialysis – infusion kits

  • 12.06

Urgent Field Safety Notice for BRONCHOSKOP-TUBUS by Richard Wolf GmbH

Optics / Precision engineering – endoscopes

  • 12.06

Urgent Field Safety Notice for Nicolet EEG Wireless Amplifier by Natus Neurological Incorporated

Medical electronics / Electromedical devices – electrodiagnostics

  • 12.06

Urgent Field Safety Notice for Binax NOW Legionella Urinary Antigen 22 Test Kit 852-000 by Alere Scarborough, Inc.

In-vitro diagnostics – equipment / products for clinical chemistry

 

  • 12.21

Urgent Field Safety Notice for Brustimplantat / verschiedene Modelle, Allergan Limited

Non-active implants – special implants

  • 12.20

Urgent Field Safety Notice by OHST Medizintechnik AG: Handling of fractured ceramic inserts and ceramic head fractures

Non-active implants – bone surgery

  • 12.20

Urgent Field Safety Notice for StealthAir Percutaneous Pin Adapter by Medtronic Navigation Inc.

Radiological technology – navigation systems

  • 12.20

Urgent Field Safety Notice for Push Valve / Mag Valve by Ottobock S. & Co. KGaA

Orthopaedic / Rehabilitation technology – orthoses

  • 12.20

Urgent Field Safety Notice for MAVIG Portegra/Portegra2 Overhead Counterpoise System by Bayer Medical Care Inc.

Injections / Infusions / Transfusions / Dialysis – infusion technology

  • 12.20

Urgent Field Safety Notice for IVUS Katheter by Philips Volcano

Ultrasonics – ultrasonic diagnostic equipment

  • 12.20

Urgent Field Safety Notice for SurdialTM X by Nipro Corporation

Injections / Infusions / Transfusions / Dialysis – dialysis technology

  • 12.19

Urgent Field Safety Notice for Stryker model Nära Hospital Bassinet by Stryker Medical-Kalamazoo

General equipment for medical treatment – furnishings

  • 12.19

Urgent Field Safety Notice for BIOLOX delta Pfanneneinsatz Größe Ø 36/44 mm by implantcast GmbH

Non-active implants – bone surgery

  • 12.19

Urgent Field Safety Notice for Tritanium PL Spinal Cage by Stryker Spine-US

Non-active implants – bone surgery

  • 12.19

Urgent Field Safety Notice for SiroLaser Blue by Sirona Dental Systems GmbH

Dental products – equipment

  • 12.19

Urgent Field Safety Notice for Visum LED by Stryker Communications

Surgical equipment/ Anaesthesia – surgical equipment

  • 12.18

Urgent Field Safety Notice for PLATINIUM by MicroPort CRM S.r.l.

Active implantable medical devices – defibrillators

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  • 12.18

Urgent Field Safety Notice for CELLEX Photopheresis System by Therakos Inc. (Bedminster)

Injections / Infusions / Transfusions / Dialysis – therapeutic apheresis procedures

  • 12.18

Urgent Field Safety Notice for MOSAIQ and Sequencer by Elekta Inc., Sunnyvale

Radiotherapy / Radiation protection – radiotherapy treatment planning systems

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