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Urgent Field Safety Notice for Multilevel Saliva Calibrator Set and Cortisol Cortison Control Level I and II by Chromsystems Instruments & Chemicals GmbH PDF, 2MB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 18436/20

Urgent Field Safety Notice for Mentype Chimera CE-IVD by Biotype Diagnostic GmbH PDF, 154KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - others
Reference 17075/20

Urgent Field Safety Notice for ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) by Roche Diagnostics GmbH PDF, 637KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 11481/19

Urgent Field Safety Notice for Bilirubin Direct / Total, Creatinine Jaffe/Enz. by Thermo Fisher Scientific Oy PDF, 123KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16281/20

Urgent Field Safety Notice for various FTD products by Fast-Track Diagnostics S.a.r.l. PDF, 164KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 17169/19

Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Analyzer,iQ200 Urine Microscopy Analyzer by Beckman Coulter Ireland Inc. PDF, 88KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04617/20

Urgent Field Safety Notice for Actim CRP by ActimOy PDF, 3MB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 16366/20

Urgent Field Safety Notice for Optilite Analyser by The Binding Site Group Limited PDF, 441KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04982/20

Urgent Field Safety Notice for BÜHLMANN GanglioCombiTM MAG ELISA by Bühlmann Laboratories AG PDF, 113KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 17159/20

Urgent Field Safety Notice for VIDAS FT4 by bioMérieux S. (Marcy- l'Etoile) PDF, 279KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 16983/20

Urgent Field Safety Notice for Prevo-Check by Abviris Deutschland GmbH PDF, 1MB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 18552/20

Urgent Field Safety Notice for CancerCheck CEA by concile GmbH PDF, 263KB, File does not meet accessibility standards Date: 10. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 16767/20

Urgent Field Safety Notice for KWIK-STIK 2or6 Pack 01145 /QC Sets&Panels 5226P by Microbiologics, Inc. PDF, 153KB, File does not meet accessibility standards Date: 09. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 18873/20

Urgent Field Safety Notice for KWIK-STIK, KWIK-STIK Plus and LYFO DISK by Microbiologics, Inc. PDF, 152KB, File does not meet accessibility standards Date: 09. November 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 18872/20

Urgent Field Safety Notice for FCR Profect CS Plus by FUJIFILM Corporation PDF, 234KB, File does not meet accessibility standards Date: 06. November 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 16306/20

Urgent Field Safety Notice for Saver One by A.M.I. Italia S.R.L. PDF, 700KB, File does not meet accessibility standards Date: 05. November 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 14483/20

Urgent Field Safety Notice for MyLab Diverse by Esaote S.p.A. PDF, 209KB, File does not meet accessibility standards Date: 05. November 2020 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 18751/20

Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd. PDF, 288KB, File does not meet accessibility standards Date: 04. November 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 14506/20

Urgent Field Safety Notice for Breelib Starter Pack, Breelib Monthly Pack by Vectura Group plc PDF, 367KB, File does not meet accessibility standards Date: 03. November 2020 Topics: Medical devices Type: Customer information

Product group Physical therapy - inhalation therapy
Reference 00494/20

Urgent Field Safety Notice for Cardioblate CryoFlex 10-S Surgical Ablation Probe by Medtronic Inc PDF, 62KB, File does not meet accessibility standards Date: 03. November 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 18392/20

Urgent Field Safety Notice for EKOS Control System 4.0 by EKOS Corporation PDF, 1MB, File does not meet accessibility standards Date: 03. November 2020 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 07057/19

Urgent Field Safety Notice for neuromate stereotactic system by RENISHAW mayfield PDF, 304KB, File does not meet accessibility standards Date: 30. October 2020 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 16997/20

Urgent Field Safety Notice for Trevo XP ProVue Retriever 4x20 by Stryker Neurovascular-Utah-Salt Lake City PDF, 425KB, File does not meet accessibility standards Date: 29. October 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 16411/20

Urgent Field Safety Notice for PERFORATOR BIT LARGE 14/11MM by Stryker Instruments-Kalamazoo PDF, 155KB, File does not meet accessibility standards Date: 29. October 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 17934/20

Urgent Field Safety Notice for Heater Unit HU 35, Rotaflow System, Rotaflow Systtem with Rotaflow ICU Console by Maquet Cardiopulmonary GmbH PDF, 857KB, File does not meet accessibility standards Date: 28. October 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12117/20

Urgent Field Safety Notice for AESCULAP AEOS by Aesculap AG PDF, 2MB, File does not meet accessibility standards Date: 27. October 2020 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 17677/20

Urgent Field Safety Notice for 3M Red Dot Universal EKG-Elektrode by 3M Health Care PDF, 487KB, File does not meet accessibility standards Date: 27. October 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 16878/20

Urgent Field Safety Notice for Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System by Medtronic CoreValve, LLC PDF, 264KB, File does not meet accessibility standards Date: 27. October 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 17955/20

Urgent Field Safety Notice for Etermis 3 and 4 by Merz Pharmaceuticals GmbH PDF, 71KB, File does not meet accessibility standards Date: 27. October 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 17413/20

Urgent Field Safety Notice for DE-Einmal Laryngoskop-Griff Erwachsene LED mit B. by P.J. Dahlhausen & Co. GmbH PDF, 2MB, File does not meet accessibility standards Date: 27. October 2020 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 18056/20