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Urgent Field Safety Notice for Vamp Optima by Edwards Lifesciences LLC PDF, 470KB, File does not meet accessibility standards Date: 02. April 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 04052/19

Urgent Field Safety Notice for Alu CARLO Classic by Beka Hospitec GmbH PDF, 332KB, File does not meet accessibility standards Date: 01. April 2019 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 03527/19

Urgent Field Safety Notice for CompoStop by Fresenius Kabi Deutschland GmbH PDF, 83KB, File does not meet accessibility standards Date: 01. April 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 04025/19

Urgent Field Safety Notice for Detector Mounting Screws for Nuclear Medicine Systems by GE Medical Systems Israel, Functional Imaging PDF, 173KB, File does not meet accessibility standards Date: 29. March 2019 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 03934/19

Urgent Field Safety Notice for MRIdian Linac System by ViewRay Inc. PDF, 9MB, File does not meet accessibility standards Date: 29. March 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 03998/19

Urgent Field Safety Notice for Breathing circuits VentStar Helix by Dräger Medical GmbH jetzt Drägerwerk AG & Co. KGaA PDF, 1MB, File does not meet accessibility standards Date: 29. March 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03944/19

Urgent Field Safety Notice for Ventrikelkatheter by Christoph Miethke GmbH & CoKG PDF, 2MB, File does not meet accessibility standards Date: 29. March 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 02906/19

Urgent Field Safety Notice for Bohrloch Reservoir Set by Christoph Miethke GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 29. March 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 02901/19

Urgent Field Safety Notice for Endo Clinch II Auto Suture Grasper 5mm and Endo Grasp Auto Suture Grasper 5mm by Covidien llc PDF, 401KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 03721/19

Urgent Field Safety Notice for Cios Spin by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 140KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 03860/19

Urgent Field Safety Notice for AIR Anterior Array by GE Healthcare Coils PDF, 118KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 03900/19

Urgent Field Safety Notice for RT Elements by Brainlab AG PDF, 409KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 03887/19

Urgent Field Safety Notice for Geistlich Bio-Oss Pen by Geistlich Pharma AG PDF, 110KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 03452/19

Urgent Field Safety Notice for PADSY-Holter by Medset Medizintechnik GmbH PDF, 3MB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03868/19

Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 168KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 03861/19

Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda) PDF, 199KB, File does not meet accessibility standards Date: 28. March 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 02582/19

Urgent Field Safety Notice for BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM by Invacare Deutschland GmbH PDF, 162KB, File does not meet accessibility standards Date: 27. March 2019 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 03625/19

Urgent Field Safety Notice for S. AIA-PACK ACTH by Tosoh Corporation PDF, 243KB, File does not meet accessibility standards Date: 27. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03451/19

Urgent Field Safety Notice for S. AIA-PACK Homocysteine by Tosoh Corporation PDF, 243KB, File does not meet accessibility standards Date: 27. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03453/19

Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC PDF, 483KB, File does not meet accessibility standards Date: 27. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03555/19

Urgent Field Safety Notice for cobas 8000 by Hitachi High-Technologies Corporation PDF, 494KB, File does not meet accessibility standards Date: 27. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03045/19

Urgent Field Safety Notice for MAJ-209 SINGLE USE SUCTION VALVE by Olympus Medical Systems Corp. PDF, 216KB, File does not meet accessibility standards Date: 27. March 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 03081/19

Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC PDF, 2MB, File does not meet accessibility standards Date: 26. March 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 03758/19

Urgent Field Safety Notice for SONOLITH I-SYS by EDAP TMS France S.A. PDF, 637KB, File does not meet accessibility standards Date: 26. March 2019 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic therapeutic equipment
Reference 00688/19

Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH & Co. KG PDF, 275KB, File does not meet accessibility standards Date: 25. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02841/19

Urgent Field Safety Notice for ARIES products by Luminex Corporation PDF, 4MB, File does not meet accessibility standards Date: 25. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 02484/19

Urgent Field Safety Notice for FTD Fever and rash by Fast Track Diagnostics Luxembourg S.à.r.l PDF, 251KB, File does not meet accessibility standards Date: 25. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 02231/19

Urgent Field Safety Notice for recomLine Helicobacter 2.0 IgG/IgA by Mikrogen GmbH PDF, 2MB, File does not meet accessibility standards Date: 25. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03119/19

Urgent Field Safety Notice for ENAcombi (ORG 514) by Orgentec Diagnostika GmbH PDF, 806KB, File does not meet accessibility standards Date: 25. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03351/19

Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 69KB, File does not meet accessibility standards Date: 25. March 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03458/19