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Urgent Field Safety Notice for O-ARM Imaging System by Medtronic Navigation Inc. PDF, 743KB, File does not meet accessibility standards Date: 16. January 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 15925/19

Urgent Field Safety Notice for 8 mm Endoscope and Camera Head Sterilization Tray by Intuitive Surgical, Inc. PDF, 570KB, File does not meet accessibility standards Date: 15. January 2020 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 17267/19

Urgent Field Safety Notice for GORE EXCLUDER AAA Endoprosthesis & GORE IBE by W.L. Gore & Associates, Inc. PDF, 693KB, File does not meet accessibility standards Date: 15. January 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 17270/19

Urgent Field Safety Notice for RotaFlow Drive by Maquet Cardiopulmonary GmbH PDF, 85KB, File does not meet accessibility standards Date: 15. January 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 15505/19

Urgent Field Safety Notice for Aequalis Ascend Flex Shoulder System by TORNIER SAS PDF, 7MB, File does not meet accessibility standards Date: 15. January 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 15139/19

Urgent Field Safety Notice for Closed Suction System for Neonates / Pediatrics, 5 F, Y-Adapter by Avanos Medical Inc PDF, 127KB, File does not meet accessibility standards Date: 15. January 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 15478/19

Urgent Field Safety Notice for Rusch GreenLite MAC (diverse Größen) by Teleflex Medical Athlone PDF, 153KB, File does not meet accessibility standards Date: 15. January 2020 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 00382/20

Urgent Field Safety Notice for Epicite hydro by JeNaCell GmbH PDF, 429KB, File does not meet accessibility standards Date: 13. January 2020 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 17294/19

Urgent Field Safety Notice for 1.5T SIGNA HDxt, SIGNA Architect, SIGNA Pioneer, SIGNA Premier by GE Medical Systems, LLC PDF, 248KB, File does not meet accessibility standards Date: 13. January 2020 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 00227/20

Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB PDF, 129KB, File does not meet accessibility standards Date: 13. January 2020 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 17355/19

Urgent Field Safety Notice for Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 3MB, File does not meet accessibility standards Date: 13. January 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 00246/20

Urgent Field Safety Notice for BARD Site~Rite 8 Ultrasound System by Bard Access Systems Division (BASD) PDF, 200KB, File does not meet accessibility standards Date: 13. January 2020 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 00218/20

Urgent Field Safety Notice for PowerMAG (in USA als Systembildung mit IT Komponenten: Apollo) by MAG & More GmbH PDF, 578KB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for magnet therapy
Reference 11431/19

Urgent Field Safety Notice for Insufflationsschlauchset, mit Gasfilter by Karl Storz S. & Co KG PDF, 74KB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 17055/19

Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH PDF, 129KB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 00062/20

Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH PDF, 123KB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 00068/20

Urgent Field Safety Notice for Arrow PICC, Epiduralkatheter, Abdecktuch, Nadel für kontinuierliche Nervenblockade etc. by Arrow International Inc. PDF, 147KB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - other products for injections / infusions / transfusions / dialysis
Reference 00141/20

Urgent Field Safety Notice for CTG7 fetal/maternal monitor by Philips Goldway (Shenzhen) Industrial Inc. PDF, 2MB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 17269/19

Urgent Field Safety Notice for Sterilizable handle "Hanaulux" by MAQUET SAS PDF, 308KB, File does not meet accessibility standards Date: 09. January 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 16943/19

Urgent Field Safety Notice for Basissets mit Papp-Nierenschalen by Smiths Medical ASD, Inc. (Plymouth) PDF, 294KB, File does not meet accessibility standards Date: 08. January 2020 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - others
Reference 00116/20

Urgent Field Safety Notice for Bronchoscope by Olympus Medical Systems Corp. PDF, 451KB, File does not meet accessibility standards Date: 07. January 2020 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 16677/19

Urgent Field Safety Notice for All Linacs with COHERENCE ONCOLOGIST RT* by Siemens Healthcare GmbH, Advanced Therapies, Radiation Oncology PDF, 161KB, File does not meet accessibility standards Date: 07. January 2020 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 00021/20

Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland B.V. PDF, 99KB, File does not meet accessibility standards Date: 07. January 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 00026/20

Urgent Field Safety Notice for IDRT - Single Layer and IDRT TS by Integra LifeSciences Corporation PDF, 276KB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 17596/19

Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies PDF, 1MB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 17350/19

Urgent Field Safety Notice for Centricity Universal Viewer by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc PDF, 236KB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - data processing facilities for image processing
Reference 17563/19

Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc PDF, 560KB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 17185/19

Urgent Field Safety Notice for PatientOnLine by Fresenius Medical Care AG & Co. KGaA PDF, 43KB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 17170/19

Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS PDF, 660KB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 16675/19

Urgent Field Safety Notice for Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep by Mavidon PDF, 221KB, File does not meet accessibility standards Date: 06. January 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 13342/19