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Urgent Field Safety Notice for Intro-Flex Percutaneous Sheath Introducers [Tray, 9F high-flow] by Edwards Lifesciences LLC PDF, 476KB, File does not meet accessibility standards Date: 23. May 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06852/19

Urgent Field Safety Notice for CELL-DYN Emerald; Emerald Diluent Tubing by Abbott Laboratories (Abbott Park) PDF, 112KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 06245/19

Urgent Field Safety Notice for ARCHITECT c4000 / c8000 / c16000 Mixer by Abbott Laboratories (Abbott Park) PDF, 243KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05726/19

Urgent Field Safety Notice for RNeasy DSP FFPE Kit by QIAGEN GmbH PDF, 512KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05748/19

Urgent Field Safety Notice for Procleix HEV Assay by Grifols Diagnostic Solutions Inc. - Emeryville PDF, 547KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04801/19

Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS PDF, 8KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07483/18

Urgent Field Safety Notice for MAS ChemTRAK H Assayed Control Level 3 by Microgenics Corporation PDF, 185KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02858/19

Urgent Field Safety Notice for Atellica and ADVIA Creatine Kinase (CK_L) Reagent by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 241KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06544/19

Urgent Field Safety Notice for VIDAS NT-proBNP2 by bioMérieux S. (Marcy- l'Etoile) PDF, 765KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06577/19

Urgent Field Safety Notice for Mentype AMLplexQS by Biotype Diagnostic GmbH PDF, 148KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 05133/19

Urgent Field Safety Notice for Rim Platte, 10-Loch, Links, PRS RX System by I.T.S. GmbH PDF, 137KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06259/19

Urgent Field Safety Notice for Mindray- ; Weinmann defibrillation electrodes by Leonhard Lang Medizintechnik GmbH PDF, 299KB, File does not meet accessibility standards Date: 21. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06495/19

Urgent Field Safety Notice for GAMMA SUPII by CLERAD (CLERmont RAyonnement Détection) PDF, 111KB, File does not meet accessibility standards Date: 20. May 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - nuclear medical therapeutic equipment
Reference 05760/19

Urgent Field Safety Notice for My Therapy App for Sacral Neuromodulation Therapy by Medtronic Inc PDF, 100KB, File does not meet accessibility standards Date: 20. May 2019 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - medical apps
Reference 06469/19

Urgent Field Safety Notice for Electronic Patient Gas System Flowmeter - APS1 by Terumo Cardiovascular Systems Corporation PDF, 522KB, File does not meet accessibility standards Date: 20. May 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06620/19

Urgent Field Safety Notice for Druckmess-Sets; 1-fach, 2-fach, oder mit ZVD-Messschenkel sowie Arterielles Blutentnahmesystem by Codan pvb Critical Care GmbH PDF, 181KB, File does not meet accessibility standards Date: 20. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electronic blood pressure monitor
Reference 04539/19

Urgent Field Safety Notice for ThermaCare by Pfizer Consumer Health Care PDF, 100KB, File does not meet accessibility standards Date: 17. May 2019 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 05759/19

Urgent Field Safety Notice for Chromophare by Berchtold GmbH & Co. KG PDF, 425KB, File does not meet accessibility standards Date: 16. May 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04799/19

Urgent Field Safety Notice for EVIS LUCERA DUODENOVIDEOSCOPE by Olympus Medical Systems Corp. PDF, 212KB, File does not meet accessibility standards Date: 16. May 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 05847/19

Urgent Field Safety Notice for Olea Sphere V3.0 IFU by OLEA MEDICAL S.A.S PDF, 3MB, File does not meet accessibility standards Date: 16. May 2019 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - software for MR tomography
Reference 05553/19

Urgent Field Safety Notice for Philips-EPIQ and Affiniti Ultrasound system by Philips Healthcare, Philips Ultrasound PDF, 80KB, File does not meet accessibility standards Date: 16. May 2019 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 06458/19

Urgent Field Safety Notice for Sinapi Chest Drain by Sinapi Biomedical (Pty) Ltd PDF, 48KB, File does not meet accessibility standards Date: 15. May 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 06332/19

Urgent Field Safety Notice for AstraT, AzureT, PerceptaT, SerenaT, SolaraT by Medtronic Inc PDF, 53KB, File does not meet accessibility standards Date: 14. May 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 06210/19

Urgent Field Safety Notice for Philips SureSigns VS Monitors by Philips Medical Systems PDF, 2MB, File does not meet accessibility standards Date: 13. May 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 05373/19

Urgent Field Safety Notice for Alinity c Cuvette Segment by Abbott GmbH & Co. KG PDF, 588KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05072/19

Urgent Field Safety Notice for Alere NT-proBNP Control/Alere NT-proBNP Calibrator by Axis-Shield Diagnostics Limited PDF, 101KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 05386/19

Urgent Field Safety Notice for SureTyper Software by Linkage Biosciences, Inc. PDF, 2MB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 05198/19

Urgent Field Safety Notice for STA-NeoPTimal 20 with STA-Compact/STA-Compact Max by Stago PDF, 141KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 04834/19

Urgent Field Safety Notice for Oxoid Ceftriaxone 32 M.I.C.Evaluator strip MA0122 by Thermofisher Scientific PDF, 185KB, File does not meet accessibility standards Date: 10. May 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04800/19