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2018.07.05 Urgent Field Safety Notice for Volista by MAQUET SAS Surgical equipment/ Anaesthesia - surgical equipment PDF2MB 2018.07.04 Urgent Field Safety Notice for VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS by Olympus Medical Systems Corp. Optics / Precision engineering - endoscopes PDF212KB 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 PDF146KB 2018.07.04 Urgent Field Safety Notice for Palacos und Copal Knochenzemente by Heraeus Medical GmbH Non-active implants - materials for implants PDF1MB 2018.07.03 Urgent Field Safety Notice for Hydraulic Ureter Dilators by Teleflex Medical Injections / Infusions / Transfusions / Dialysis - catheters PDF135KB 2018.07.03 Urgent Field Safety Notice for End Ball by Laboratoire ENDALIS Non-active implants - special implants PDF2MB 2018.07.03 Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme Physical therapy - massage / mobility devices PDF151KB 2018.07.02 Urgent Field Safety Notice for SQUALE by Orthopaedic & Spine Development Non-active implants - bone surgery PDF294KB 2018.07.13 Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS In-vitro diagnostics - equipment / products for clinical chemistry PDF358KB 2018.07.13 Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc. Tarrytown In-vitro diagnostics - equipment / products for clinical chemistry PDF115KB 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 PDF151KB 2018.07.11 Urgent Field Safety Notice for EMU40 by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Medical electronics / Electromedical devices - electrodiagnostics PDF110KB 2018.07.11 Urgent Field Safety Notice for Raucodrape camera drape 16x250 in set Kitpack by Lohmann und Rauscher GmbH & Co. KG Surgical equipment/ Anaesthesia - surgical equipment PDF61KB 2018.07.11 Urgent Field Safety Notice for SAFIL & NOVOSYN by B. Braun Surgical S.A. Dressings / Pads - surgical sutures, vascular loops etc. PDF787KB 2018.07.10 Urgent Field Safety Notice for FUJIFILM Flexible Duodenoscope by FUJIFILM Corporation Optics / Precision engineering - endoscopes PDF74KB 2018.07.10 Urgent Field Safety Notice for OrthoScan Mini C-Arm X-Ray System by OrthoScan, Inc. Radiological technology - mobile radiological diagnostic facilities PDF82KB 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 PDF199KB 2018.07.09 Urgent Field Safety Notice for VISIONAIRE LIGHTWEIGHT ALIGNMENT ROD by Smith & Nephew, Inc., Medical instruments for use in humans - bone surgery PDF193KB 2018.07.09 Urgent Field Safety Notice for MATRIX DS by XION GmbH Optics / Precision engineering - endoscopes PDF281KB 2018.07.09 Urgent Field Safety Notice for Guardian Connect Application by Medtronic Minimed Medical data processing (software) - others PDF74KB 2018.07.06 Urgent Field Safety Notice for Leksell GammaPlan by Elekta Instrument AB Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF126KB 2018.07.06 Urgent Field Safety Notice for Alaris/ Asena GS,GH,CC,TIVA,PK, Syringe Pumps by CareFusion Switzerland 317 Sarl Injections / Infusions / Transfusions / Dialysis - infusion technology PDF238KB 2018.07.05 Urgent Field Safety Notice for ProteusPLUS by IBA (Ion Beam Applications) Radiotherapy / Radiation protection - nuclear medical therapeutic equipment PDF1MB 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 PDF664KB 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 PDF283KB 2018.07.13 Urgent Field Safety Notice for LCD Power supply (LPS) by NordicNeuroLab AS Electromedical fields - equipment for MR tomography PDF219KB 2018.07.13 Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC In-vitro diagnostics - microbiological products PDF148KB 2018.07.13 Urgent Field Safety Notice for Vitamin D total II, Elecsys Vitamin D total II by Roche Diagnostics GmbH In-vitro diagnostics - equipment / products for clinical chemistry PDF131KB 2018.07.13 Urgent Field Safety Notice for Pereyra-Raz Ligature Carrier, Pereyra Ligature Carrier '75, Stamey Needle by Cook Incorporated Medical instruments for use in humans - general instruments PDF313KB 2018.07.13 Urgent Field Safety Notice for MagNA Pure 24 System by Roche Diagnostics GmbH In-vitro diagnostics - equipment / products for clinical chemistry PDF115KB 2018.07.13 Urgent Field Safety Notice for QMS Teicoplanin Calibrator by Microgenics Corporation In-vitro diagnostics - equipment / products for clinical chemistry PDF96KB 2018.07.13 Urgent Field Safety Notice for CellSearch Circulating Tumor Cell Kit 7900001, CellSearch Epithelial Cell Kit 7900000 by Menarini Silicon Biosystems lnc. In-vitro diagnostics - immunological products PDF215KB 2018.07.13 Urgent Field Safety Notice for Monoclonal Mouse Anti-Human MSH2 FE11 by Dako North America, Inc. In-vitro diagnostics - microbiological products PDF103KB 2018.07.13 Urgent Field Safety Notice for Perifix Catheter Connector by B. Braun Melsungen AG Injections / Infusions / Transfusions / Dialysis - infusion technology PDF61KB 2018.07.13 Urgent Field Safety Notice for LeadcareII/Leadcare Plus by Magellan Diagnostics Inc. In-vitro diagnostics - haematological, histological and cytological products PDF163KB 2018.07.13 Urgent Field Safety Notice for Stamey Needle,Clarke-Reich Laparoscopic Knot Pusher,Endoscopic Introducer/Extractor,Pereyra Ligature Carrier '75,Pereyra-Raz Ligature Carrier by Cook Incorporated / Cook Vascular Medical instruments for use in humans - general instruments PDF167KB 2018.07.13 Urgent Field Safety Notice for Bond Polymer Refine Detection DS9800 by Leica Biosystems Newcastle Ltd In-vitro diagnostics - immunological products PDF100KB 2018.07.13 Urgent Field Safety Notice for Mullkompressen 5 x 5 cm by Meditrade GmbH Dressings / Pads - dressings PDF1MB 2018.07.23 Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS Medical electronics / Electromedical devices - electrotherapy PDF241KB 2018.07.23 Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF408KB 2018.07.23 Urgent Field Safety Notice for MEDUCORE Standard 2 by WEINMANN Emergency Medical Technology GmbH + Co. KG Medical electronics / Electromedical devices - electrotherapy PDF58KB 2018.07.20 Urgent Field Safety Notice for Arrow HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip by Arrow International Inc. Injections / Infusions / Transfusions / Dialysis - catheters PDF154KB 2018.07.20 Urgent Field Safety Notice for DEMOTEK Solution Administration IV set by Demophorius Healthcare LTD Injections / Infusions / Transfusions / Dialysis - transfusion kits PDF110KB 2018.07.19 Urgent Field Safety Notice for PLATINIUM by MicroPort CRM S.r.l. Active implantable medical devices - defibrillators PDF168KB 2018.07.18 Urgent Field Safety Notice for VisualaseT Thermal Therapy System by Medtronic Navigation Inc. Optics / Precision engineering - laser technology PDF95KB 2018.07.18 Urgent Field Safety Notice for Dermatome AN by Zimmer Orthopaedic Surgical Products Surgical equipment/ Anaesthesia - surgical equipment PDF229KB 2018.07.17 Urgent Field Safety Notice for Jelonet 15x 2 cm Paraffingazeverband by Smith & Nephew Medical Ltd. Dressings / Pads - dressings PDF56KB 2018.07.17 Urgent Field Safety Notice for COPAL knee moulds by Heraeus Medical GmbH Medical instruments for use in humans - bone surgery PDF368KB 2018.07.17 Urgent Field Safety Notice for Trokarkatheter gerade/ trocar thorax catheter, Ch. 28 by P. J. Dahlhausen & Co.GmbH Injections / Infusions / Transfusions / Dialysis - drainages and suction systems PDF1MB 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 PDF75KB 2018.07.16 Urgent Field Safety Notice for Sectio Set Bielefeld incl. Safil and Novosyn by Mölnlycke Health Care AB Dressings / Pads - surgical sutures, vascular loops etc. PDF2MB 2018.07.16 Urgent Field Safety Notice for Chorion Villus Biopsy Needle Set by William A. Cook Australia Pty. Ltd. Medical instruments for use in humans - general instruments PDF437KB 2018.07.16 Urgent Field Safety Notice for OPAT RESERVOIR by Haemonetics Corporation Injections / Infusions / Transfusions / Dialysis - transfusion kits PDF250KB 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 PDF234KB 2018.07.26 Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS In-vitro diagnostics - equipment / products for clinical chemistry PDF43KB 2018.07.26 Urgent Field Safety Notice for Xpert C.Difficile BT by Cepheid AB, Solna In-vitro diagnostics - microbiological products PDF80KB 2018.07.26 Urgent Field Safety Notice for Xpert MTB/RIF Ultra by Cepheid AB, Solna In-vitro diagnostics - microbiological products PDF65KB 2018.07.26 Urgent Field Safety Notice for IMMULITE / IMMULITE 1000 Insulin, IMMULITE 2000 / 2000 XPi Insulin by Siemens Healthcare Diagnostics Inc. Tarrytown In-vitro diagnostics - equipment / products for clinical chemistry PDF71KB 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 PDF2MB 2018.07.26 Urgent Field Safety Notice for NanoZoomer by Hamamatsu Photonics K+. K+., Systems Division Joko Factory In-vitro diagnostics - instruments, apparatuses and systems PDF109KB 2018.07.24 Urgent Field Safety Notice for verschiedene Therapieliegen by FREI AG- Aktive Rehasysteme Physical therapy - massage / mobility devices PDF185KB 2018.07.24 Urgent Field Safety Notice for Monnal T60 by Air Liquide Medical Systems Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF93KB 2018.07.24 Urgent Field Safety Notice for THERA-Trainer balo / THERA-Trainer verto by medica Medizintechnik GmbH Physical therapy - massage / mobility devices PDF2MB 2018.07.24 Urgent Field Safety Notice for Medumat Transport by WEINMANN Emergency Medical Technology GmbH + Co. KG Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF205KB 2018.07.24 Urgent Field Safety Notice for Hall Small Lithium Battery by ConMed Corporation Surgical equipment/ Anaesthesia - surgical equipment PDF135KB 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 PDF67KB 2018.07.23 Urgent Field Safety Notice for LEDVISION by Surgiris S.A.S. Surgical equipment/ Anaesthesia - surgical equipment PDF7MB 2018.07.23 Urgent Field Safety Notice for Applimed cannula needle straight with olive, 100mm, stainless steel, G18,diameter 1.19mm, included in Medline Sterile Procedure Trays by Medline International France SAS 2018.08.03 Urgent Field Safety Notice for ENNOVATE ROD PERSUADER by Aesculap AG Medical instruments for use in humans - bone surgery PDF2MB 2018.08.03 Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC Non-active implants - bone surgery PDF260KB 2018.07.31 Urgent Field Safety Notice for VITROS Folate; FreePSA; FSH; Prolactin; TSH by Ortho Clinical Diagnostics UK In-vitro diagnostics - immunological products PDF1MB 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 PDF1MB 2018.07.31 Urgent Field Safety Notice for sterile Lochschrauben by aap Implantate AG Non-active implants - bone surgery PDF4MB 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 PDF2MB 2018.07.30 Urgent Field Safety Notice for ARCHITECT Creatine Kinase by Abbott Laboratories In-vitro diagnostics - equipment / products for clinical chemistry PDF115KB 2018.07.30 Urgent Field Safety Notice for Human IgM Kit for SPA PLUS - NK012.S by The Binding Site Group Limited In-vitro diagnostics - microbiological products PDF4MB 2018.07.30 Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG In-vitro diagnostics - equipment / products for clinical chemistry PDF121KB 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 PDF114KB 2018.07.30 Urgent Field Safety Notice for recomWell Borrelia IgM by Mikrogen GmbH In-vitro diagnostics - microbiological products PDF1MB 2018.07.27 Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda) Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF564KB 2018.07.26 Urgent Field Safety Notice for VIDAS CA 15-3 by bioMérieux S. (Marcy- l'Etoile) In-vitro diagnostics - immunological products PDF123KB 2018.07.26 Urgent Field Safety Notice for EZ1 Advanced XL by QIAGEN GmbH In-vitro diagnostics - equipment / products for clinical chemistry PDF391KB 2018.07.26 Urgent Field Safety Notice for ARCHITECT c4000 / c8000 / c16000 Processing Module by Abbott Laboratories (Abbott Park) In-vitro diagnostics - equipment / products for clinical chemistry PDF162KB 2018.08.09 Urgent Field Safety Notice for AXIOM MULTIX, MT, ACSS,P,N, AXIOM MULTIX, MT, ACSS,N, AXIOM MULTIX, MT, AXIOM Vertix Solitaire M-System_T, AXIOM ARISTOS VX Plus by Siemens Healthcare GmbH, X-Ray Products (XP) Radiological technology - stationary radiological equipment PDF3MB 2018.08.09 Urgent Field Safety Notice for Stellaris Elite Single Port Vitrectomy Cutters by Bausch & Lomb Inc ophthalmological technology - equipment for ophthalmological therapeutics PDF172KB 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) PDF208KB 2018.08.09 Urgent Field Safety Notice for M300 by Draeger Medical Systems, Inc Medical electronics / Electromedical devices - electrodiagnostics PDF1MB 2018.08.08 Urgent Field Safety Notice for Knob Assembly contained in MAYFIELD by Integra LifeSciences Corp Surgical equipment/ Anaesthesia - surgical equipment PDF809KB 2018.08.08 Urgent Field Safety Notice for TRENDHIP STANDARD CEM.LESS 12/14 SIZE 2 by Groupe Lepine Non-active implants - bone surgery PDF25KB 2018.08.08 Urgent Field Safety Notice for Zytologiebürste Einweg by FENDO Medizinztechnik e.K. Medical instruments for use in humans - cardiac/thorax surgery PDF46KB 2018.08.07 Urgent Field Safety Notice for GC85A, GM85, GC80, GC70, GU60A, GF50, and GR40CW by Samsung Electronics Co. Limited Radiological technology - stationary radiological equipment PDF90KB 2018.08.07 Urgent Field Safety Notice for Alcon LuxOR E71 Ophthalmic Microscope; Alcon LuxOR E71 Q-Vue Ophthalmic by Alcon Laboratories, Inc. Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes) PDF170KB 2018.08.07 Urgent Field Safety Notice for Sonolith i-move by EDAP TMS France S.A. Ultrasonics - ultrasonic therapeutic equipment PDF1MB 2018.08.07 Urgent Field Safety Notice for MAKO Vizadisc Knee/Hip Procedure Tracking Kit by MAKO Surgical Corp. Surgical equipment/ Anaesthesia - surgical equipment PDF151KB 2018.08.06 Urgent Field Safety Notice for Dr. Mach Operationsleuchte mit Schwerer Zentralachse by Dr. Mach GmbH & Co. KG Surgical equipment/ Anaesthesia - surgical equipment PDF135KB 2018.08.06 Urgent Field Safety Notice for MyLab Diverse by Esaote S.p.A. Ultrasonics - ultrasonic diagnostic equipment PDF94KB 2018.08.06 Urgent Field Safety Notice for Ureterorenoskop; Ureterorenoskop; Nephroskop by Schölly Fiberoptic GmbH Optics / Precision engineering - endoscopes PDF2MB 2018.08.06 Urgent Field Safety Notice for LipiVage Harvester w/Cannula by Genesis Biosystems Surgical equipment/ Anaesthesia - surgical equipment PDF9KB 2018.08.20 Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG General equipment for medical treatment - cleaning / disinfection / sterilisation PDF2MB 2018.08.20 Urgent Field Safety Notice for Organ Care System (OCS) Heart by TransMedics, Inc. Surgical equipment/ Anaesthesia - surgical equipment PDF228KB 2018.08.20 Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG Non-active implants - special implants PDF245KB 2018.08.20 Urgent Field Safety Notice for sterEOS workstation by EOS imaging Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine PDF307KB 2018.08.20 Urgent Field Safety Notice for Durex "Real Feel" Polyisoprene Condoms by Reckitt Benckiser Healthcare International Contraception - condoms PDF87KB 2018.08.20 Urgent Field Safety Notice for Miele Sterilisatoren by Miele & Cie. KG General equipment for medical treatment - cleaning / disinfection / sterilisation PDF3MB 2018.08.20 Urgent Field Safety Notice for Hemodialysis Products by Medcomp Medical Components, Inc. Injections / Infusions / Transfusions / Dialysis - catheters PDF311KB 2018.08.20 Urgent Field Safety Notice for BIS Vista and BIS View Monitoring Systems by Covidien llc Medical electronics / Electromedical devices - electrodiagnostics PDF998KB 2018.08.20 Urgent Field Safety Notice for RYTHMIC EVOLUTION by MICREL MEDICAL DEVICES SA Injections / Infusions / Transfusions / Dialysis - infusion technology PDF312KB 2018.08.20 Urgent Field Safety Notice for MobileDiagnost wDR by Philips Medical Systems DMC GmbH Radiological technology - stationary radiological equipment PDF56KB 2018.08.20 Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd. Medical data processing (software) - others PDF294KB 2018.08.10 Urgent Field Safety Notice for Philips SureSigns VS & VM Monitors, and View Stati by Philips Medical Systems Medical electronics / Electromedical devices - electrodiagnostics PDF280KB 2018.08.10 Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AG Surgical equipment/ Anaesthesia - surgical equipment PDF30KB 2018.08.09 Urgent Field Safety Notice for Ysio, Ysio Max, Ysio Fully, Ysio Semi by Siemens Healthcare GmbH, X-Ray Products (XP) Radiological technology - stationary radiological equipment PDF3MB 2018.08.09 Urgent Field Safety Notice for AEROtube-ET01-65M-SET, Endotrachealtubus-SET,mit Manschette, einzeln steril verpackt, 6,5 mm,CH 26 by HUM Gesellschaft für Homecare und Medizintechnik mbH Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF7MB 2018.08.21 Urgent Field Safety Notice for ARCHITECT EBV VCA IgM Controls by Abbott GmbH & Co.KG In-vitro diagnostics - microbiological products PDF100KB 2018.08.21 Urgent Field Safety Notice for Minicon Clinical Sample Concentrators by Merck Millipore Ltd In-vitro diagnostics - equipment / products for clinical chemistry PDF60KB 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 PDF739KB 2018.08.21 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 PDF65KB 2018.08.21 Urgent Field Safety Notice for Oxoid CT0159B by Remel Europe. Part of Thermo Fisher Scientific In-vitro diagnostics - microbiological products PDF86KB 2018.08.21 Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG Non-active implants - special implants PDF217KB 2018.08.21 Urgent Field Safety Notice for power supply for div. sleep therapy devices by Löwenstein Medical Technology GmbH + Co. KG Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF115KB 2018.08.21 Urgent Field Safety Notice for RAPIDPoint 405 500 and RAPIDLab 1245 1265 by Siemens Healthcare Diagnostics Inc. Tarrytown In-vitro diagnostics - equipment / products for clinical chemistry PDF66KB 2018.08.20 Urgent Field Safety Notice for AIRO Mobile CT System by Mobius Imaging, LLC Radiological technology - CT scanners PDF340KB 2018.08.20 Urgent Field Safety Notice for ZNN TIBIAL NAIL by Zimmer Biomet, Inc. Warsaw Non-active implants - bone surgery PDF307KB 2018.08.20 Urgent Field Safety Notice for MiniMed remote controller by Medtronic Minimed Injections / Infusions / Transfusions / Dialysis - infusion technology PDF134KB 2018.08.20 Urgent Field Safety Notice for Allura Xper and Integris Allura Systems by Philips Medical Systems Nederland B.V. Radiological technology - radiological equipment for vascular diagnostics PDF229KB 2018.08.20 Urgent Field Safety Notice for Direct Radiography system DX-D 600 by Agfa HealthCare N.V. Radiological technology - stationary radiological equipment PDF187KB 2018.08.20 Urgent Field Safety Notice for ECO Bath by CareNow Medical Pvt. Ltd. Surgical equipment/ Anaesthesia - surgical equipment PDF256KB 2018.08.20 Urgent Field Safety Notice for Endocavity Needle Guide by CIVCO Medical Instruments Co., Inc. d.b.a CIVCO Medical Solutions Medical instruments for use in humans - cardiac/thorax surgery PDF71KB 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 PDF30KB 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 PDF154KB 2018.08.22 Urgent Field Safety Notice for Cannulated Screw-sterile Lochschrauben by aap Implantate AG Non-active implants - bone surgery PDF731KB 2018.08.22 Urgent Field Safety Notice for Varilymph 12 Pro by SLK Vertriebsgesellschaft mbH Physical therapy - massage / mobility devices PDF307KB 2018.08.22 Urgent Field Safety Notice for Cardioband by Edwards Cardioband Non-active implants - cardiac surgery PDF877KB 2018.08.22 Urgent Field Safety Notice for Hiploc Plate by Biomet UK Ltd Non-active implants - bone surgery PDF135KB 2018.08.22 Urgent Field Safety Notice for DORO LUCENT Base Unit by PMI pro med Instruments GmbH Surgical equipment/ Anaesthesia - surgical equipment PDF12MB 2018.08.22 Urgent Field Safety Notice for ADVIA Centuar CKMB Calibrator/Atellica CKMB Calibrator by Siemens Healthcare Diagnostics Inc. Tarrytown In-vitro diagnostics - equipment / products for clinical chemistry PDF423KB 2018.08.22 Urgent Field Safety Notice for Ergo Just Cart by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Medical electronics / Electromedical devices - ENT equipment PDF179KB 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 PDF383KB 2018.08.21 Urgent Field Safety Notice for Transplant-Aspiration Needle, SPI-CUT by Somatex Medical Technologies GmbH / Berlin Medical instruments for use in humans - general instruments PDF361KB 2018.08.21 Urgent Field Safety Notice for Rotating IV pole by GE Healthcare Clinical Systems (Ohmeda Medical) Injections / Infusions / Transfusions / Dialysis - infusion technology PDF381KB 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 PDF710KB 2018.08.21 Urgent Field Safety Notice for Output Unit by Hitachi, Ltd. In-vitro diagnostics - equipment / products for clinical chemistry PDF101KB 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 PDF57KB 2018.08.31 Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH Surgical equipment/ Anaesthesia - surgical equipment PDF141KB 2018.08.30 Urgent Field Safety Notice for Sterile single use electrosurgical pencil by Wickimed (Huizhou) Medical Equipment Manufacturing Co Ltd Medical electronics / Electromedical devices - electrotherapy PDF93KB 2018.08.30 Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sens by Degania Silicone Ltd. Injections / Infusions / Transfusions / Dialysis - catheters PDF1MB 2018.08.29 Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH In-vitro diagnostics - microbiological products PDF167KB 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 PDF335KB 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 PDF296KB 2018.08.29 Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH In-vitro diagnostics - immunological products PDF508KB 2018.08.29 Urgent Field Safety Notice for NeoBase Succinylacetone Assay Solution by PerkinElmer Life and Analytical Sciences, Wallac Oy In-vitro diagnostics - equipment / products for clinical chemistry PDF31KB 2018.08.29 Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS Non-active implants - special implants PDF72KB 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 PDF1MB 2018.08.24 Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc Non-active implants - bone surgery PDF397KB 2018.08.24 Urgent Field Safety Notice for Geratherm Patient Warming System UniqueTemp° Recovery, Recovery Set 1 by Geratherm Medical AG Surgical equipment/ Anaesthesia - surgical equipment PDF2MB 2018.08.24 Urgent Field Safety Notice for TrueBeam & EDGE Radiotherapy Delivery Systems by Varian Medical Systems, Inc. Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy PDF241KB 2018.08.23 Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME) Radiological technology - stationary radiological equipment PDF2MB 2018.08.23 Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC Non-active implants - bone surgery PDF371KB 2018.08.31 Urgent Field Safety Notice for Mayfield tracker by Scopis GmbH Surgical equipment/ Anaesthesia - surgical equipment PDF141KB 2018.08.30 Urgent Field Safety Notice for Sterile single use electrosurgical pencil by Wickimed (Huizhou) Medical Equipment Manufacturing Co Ltd Medical electronics / Electromedical devices - electrotherapy PDF93KB 2018.08.30 Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sens by Degania Silicone Ltd. Injections / Infusions / Transfusions / Dialysis - catheters PDF1MB 2018.08.29 Urgent Field Safety Notice for Taenia solium IgG ELISA by IBL International GmbH In-vitro diagnostics - microbiological products PDF167KB 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 PDF335KB 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 PDF296KB 2018.08.29 Urgent Field Safety Notice for IgG4 Food screen 280 ELISA by IBL International GmbH In-vitro diagnostics - immunological products PDF508KB 2018.08.29 Urgent Field Safety Notice for NeoBase Succinylacetone Assay Solution by PerkinElmer Life and Analytical Sciences, Wallac Oy In-vitro diagnostics - equipment / products for clinical chemistry PDF31KB 2018.08.29 Urgent Field Safety Notice for Zenith Alpha Thoracic Endovascular Graft by William Cook Europe ApS Non-active implants - special implants PDF72KB 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 PDF1MB 2018.08.24 Urgent Field Safety Notice for Vitality Shear-off Set Screw by Zimmer Biomet Spine, Inc Non-active implants - bone surgery PDF397KB 2018.08.24 Urgent Field Safety Notice for Geratherm Patient Warming System UniqueTemp° Recovery, Recovery Set 1 by Geratherm Medical AG Surgical equipment/ Anaesthesia - surgical equipment PDF2MB 2018.08.24 Urgent Field Safety Notice for TrueBeam & EDGE Radiotherapy Delivery Systems by Varian Medical Systems, Inc. Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy PDF241KB 2018.08.23 Urgent Field Safety Notice for Multix Fusion by Siemens Shanghai Medical Equipment Ltd. (SSME) Radiological technology - stationary radiological equipment PDF2MB 2018.08.23 Urgent Field Safety Notice for Affixus Hip Fracture Nail by Biomet Orthopedics, LLC Non-active implants - bone surgery PDF371KB 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 PDF203KB 2018.09.10 Urgent Field Safety Notice for Aptio Automation / StremaLAB Automation by Siemens Healthcare Diagnostics Inc. Tarrytown In-vitro diagnostics - equipment / products for clinical chemistry PDF88KB 2018.09.10 Urgent Field Safety Notice for Unity Drill Assembly Unit, .021 Green by Coltene/Whaledent, lnc. Dental products - instruments PDF778KB 2018.09.06 Urgent Field Safety Notice for Various brand of IV catheter by Mediplus (India) Linited Injections / Infusions / Transfusions / Dialysis - catheters PDF16MB 2018.09.06 Urgent Field Safety Notice for Y-Ventil by Sunny Medical Device (Shenzhen) Co., Ltd. Injections / Infusions / Transfusions / Dialysis - infusion technology PDF95KB 2018.09.05 Urgent Field Safety Notice for s.pump by Medos Medizintechnik AG Surgical equipment/ Anaesthesia - surgical equipment PDF385KB 2018.09.05 Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical Systems Medical electronics / Electromedical devices - electrodiagnostics PDF32KB 2018.09.04 Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray Incorporated Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF151KB 2018.09.04 Urgent Field Safety Notice for Intrafix SafeSet Standard, 180 cm by B. Braun Melsungen AG Injections / Infusions / Transfusions / Dialysis - infusion kits PDF85KB 2018.09.04 Urgent Field Safety Notice for AlarisT/ AsenaT CC, GH Syringe Pump by BD Switzerland Sarl Injections / Infusions / Transfusions / Dialysis - infusion technology PDF306KB 2018.09.04 Urgent Field Safety Notice for AlignRT by VisionRT Ltd Radiotherapy / Radiation protection - radiotherapy treatment planning systems PDF774KB 2018.09.04 Urgent Field Safety Notice for General Impactor by Stanmore Implants Worldwide Ltd Medical instruments for use in humans - bone surgery PDF489KB 2018.09.04 Urgent Field Safety Notice for AWC-Additional Working Channel by Ovesco Endoscopy AG Optics / Precision engineering - endoscopes PDF386KB 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) PDF2MB 2018.08.31 Urgent Field Safety Notice for EO-150 Ventilator by EOVE Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF110KB 2018.09.13 Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; PROPONENT, PPOPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM Active implantable medical devices - cardiac pacemakers PDF38KB 2018.09.13 Urgent Field Safety Notice for Neuro Omega by Alpha Omega Engineering Ltd. Surgical equipment/ Anaesthesia - surgical equipment PDF251KB 2018.09.12 Urgent Field Safety Notice for Cell Observer S., DirectFRAP, Laser TIRF by Carl Zeiss Microscopy GmbH Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes) PDF127KB 2018.09.11 Urgent Field Safety Notice for Getinge WD15 Claro by Getinge Disinfection AB General equipment for medical treatment - cleaning / disinfection / sterilisation PDF478KB 2018.09.11 Urgent Field Safety Notice for RePlant Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC. Dental products - dental implants PDF205KB 2018.09.10 Urgent Field Safety Notice for Cannulated tap, 5.5 mm by icotec ag Medical instruments for use in humans - bone surgery PDF2MB 2018.09.10 Urgent Field Safety Notice for Enzymatic Creatinine OSR6x204, HDL Cholesterol OSR6x87, Lipase OSR6x30 and Uric Acid OSR6x98 by Beckman Coulter Ireland Inc. In-vitro diagnostics - equipment / products for clinical chemistry PDF698KB 2018.09.10 Urgent Field Safety Notice for FLEX Monoclonal Mouse Anti-Human Progesterone Rece by Dako North America, Inc. In-vitro diagnostics - immunological products PDF46KB 2018.09.10 Urgent Field Safety Notice for ClinRep UHPLC Komplettkit Antiepileptika by RECIPE Chemicals + Instruments GmbH In-vitro diagnostics - equipment / products for clinical chemistry PDF874KB 2018.09.10 Urgent Field Safety Notice for Accu-Chek Inform II, cobas h 232 POC, CoaguChek Pro II, CoaguChek XS Plus/XS Pro by Roche Diagnostics GmbH In-vitro diagnostics - others PDF482KB 2018.09.10 Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG In-vitro diagnostics - haematological, histological and cytological products PDF117KB 2018.09.10 Urgent Field Safety Notice for NOVA FA (POL YRAD PREMIUM CSAP) by SEDECAL S. A. Radiological technology - stationary radiological equipment PDF109KB 2018.09.10 Urgent Field Safety Notice for Suction Catheters, Gastro-enteral Tubes by ConvaTec Limited Deeside Surgical equipment/ Anaesthesia - surgical equipment PDF441KB 2018.09.10 Urgent Field Safety Notice for Alinity s System by Abbott GmbH & Co. KG In-vitro diagnostics - equipment / products for clinical chemistry PDF102KB 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 PDF532KB 2018.09.21 Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc. Radiological technology - navigation systems PDF53KB 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 PDF49KB 2018.09.20 Urgent Field Safety Notice for Peek Acuity Pro by Peek Vision Ltd Medical data processing (software) - facet_09md-07 PDF107KB 2018.09.20 Urgent Field Safety Notice for AFX EndoVascular AAA System by Endologix, Inc. Non-active implants - special implants PDF367KB 2018.09.20 Urgent Field Safety Notice for Diverse Dentalimplantate by VICTORY Dental products - dental implants PDF545KB 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 PDF199KB 2018.09.17 Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC In-vitro diagnostics - microbiological products PDF171KB 2018.09.17 Urgent Field Safety Notice for Alere DDS2 Test Kit by Alere Toxicology Plc In-vitro diagnostics - equipment / products for clinical chemistry PDF43KB 2018.09.17 Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA In-vitro diagnostics - equipment / products for clinical chemistry PDF2MB 2018.09.17 Urgent Field Safety Notice for Aptio Automation by Inpeco SA In-vitro diagnostics - equipment / products for clinical chemistry PDF1MB 2018.09.17 Urgent Field Safety Notice for ALTRIX, 220-240V/50HZ, TYPE F by Stryker Medical-Kalamazoo Surgical equipment/ Anaesthesia - surgical equipment PDF626KB 2018.09.17 Urgent Field Safety Notice for Alere Triage NT-proBNP Test by Alere San Diego, Inc. In-vitro diagnostics - immunological products PDF111KB 2018.09.17 Urgent Field Safety Notice for CARESCAPE Monitor B650 by GE Healthcare Finland Oy Medical electronics / Electromedical devices - electrodiagnostics PDF540KB 2018.09.13 Urgent Field Safety Notice for Powerflex PRO PTA balloon dilation by Cordis Corporation Injections / Infusions / Transfusions / Dialysis - catheters PDF920KB 2018.09.13 Urgent Field Safety Notice for LATITUDE Programmer by Boston Scientific CRM Active implantable medical devices - cardiac pacemakers PDF225KB 2018.09.25 Urgent Field Safety Notice for FlexLab by Inpeco SA In-vitro diagnostics - instruments, apparatuses and systems PDF46KB 2018.09.25 Urgent Field Safety Notice for Single-Use, Colpo-Pneumo Occluder by Cooper Surgical Inc. Medical instruments for use in humans - gynaecology PDF232KB 2018.09.25 Urgent Field Safety Notice for SIRSCAN® DISCS Amoxicilline 2µg +Acide clavulanique 1µg by I2A - Intelligence Artificielle Applications In-vitro diagnostics - microbiological products PDF319KB 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 PDF90KB 2018.09.25 Urgent Field Safety Notice for Calibrateur HDL LDL CK-MB ref 95506 & Sérum de contrôle HDL LDLCK-MB Lipides (ref 95516 & 95526) by BIOLABO In-vitro diagnostics - equipment / products for clinical chemistry PDF201KB 2018.09.25 Urgent Field Safety Notice for ekamove 30°Seitenlagerungssystem (HIMI:11.29.1003) by ekamed GmbH & Co. KG General equipment for medical treatment - furnishings PDF1MB 2018.09.25 Urgent Field Safety Notice for Pastorex Meningitis by Bio-Rad Laboratories France In-vitro diagnostics - microbiological products PDF426KB 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 PDF189KB 2018.09.25 Urgent Field Safety Notice for PATHFAST by LSI Medience Corporation In-vitro diagnostics - equipment / products for clinical chemistry PDF521KB 2018.09.25 Urgent Field Safety Notice for GENESIS II NON POROUS C/R FEMORAL SIZE 6 RIGHT by Smith & Nephew Orthopaedics GmbH Non-active implants - bone surgery PDF115KB 2018.09.25 Urgent Field Safety Notice for Dimension Lipase / Dimension Vista Lipase by Siemens Healthcare Diagnostics Inc. Newark In-vitro diagnostics - equipment / products for clinical chemistry PDF73KB 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 PDF115KB 2018.09.21 Urgent Field Safety Notice for KURZ-Precise Schneideblock by Heinz Kurz GmbH Medizintechnik Medical instruments for use in humans - bone surgery PDF170KB 2018.09.21 Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. Active implantable medical devices - artificial hearts PDF279KB 2018.09.21 Urgent Field Safety Notice for CentriMag Blood Pumping System by Thoratec Corporation Surgical equipment/ Anaesthesia - surgical equipment PDF642KB 2018.09.26 Urgent Field Safety Notice for CrystalClear Plus, RUSCH CARE CrystalClear (PVC) Tracheostomy Cannula (no Cuff) - Set, RUSCH CrystalClear (PVC) Tracheostomy Cannula (Cuffed), RUSCH CrystalClear (PVC) Tracheostomy by Teleflex (Perak West Malaysia) Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply PDF211KB 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