Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Procornea Nederland BV, FSN-C-0490, Senso Mini Sclera PT & Senso Sclera Easy

   Procornea Nederland BV would like to inform you about a safety-relevant information which is being made voluntarily by Procornea ...

   Waarschuwing | 07-12-2020

2. implantcast GmbH, FSN-FSCA_20001, IFU/ ST: EcoFit® cup / EcoFit® cup EPORE®

   hereby, implantcast GmbH would like to advise you about a safety-relevant information which is being voluntarily issued by ...

   Waarschuwing | 01-12-2020

3. Roche Diagnostics GmbH, FSN-CN-525642 (SB-CPS-2020-009), cobas c 503 analytical unit

   Roche Diagnostics GmbH would like to inform you that they have received three customer complaints regarding low Quality Control ...

   Waarschuwing | 23-11-2020

4. Respironics California, LLC, FSN-FSCA 86600052A_IR, V60 (Plus) ventilator

   Er is een probleem geconstateerd bij de Philips V60-beademingsapparaten dat een risico kan vormen voor patiënten of gebruikers ...

   Waarschuwing | 18-11-2020

5. Galt Medcial Corp., FSN-1649395-11-16-2020-001, Centeze® /Centesis Catheter

   Centeze catheters associate with the lots referenced in this FSN may have a tip geometry with a thicker wall, resulting in a more ...

   Waarschuwing | 18-11-2020

6. ThermoFisher Scientific - Microbiology Central Reporting, FSN-2020-0008, Thermo Scientific™ Oxoid™ Brilliance™ Staph24 Agar

   A technical investigation has concluded that this batch may contain low level bacterial contamination, which is sub-surface but ...

   Waarschuwing | 30-10-2020

7. Mevion Medical Systems, Inc., FSN-FSCA_201023, MEVION S250i Proton Therapy System

   Mevion Medical Systems, Inc. meldt veiligheidswaarschuwing over MEVION S250i Proton Therapy System.

   Waarschuwing | 26-10-2020

8. KARL STORZ SE & Co. KG, FSN-20082557, KARL STORZ OR1 FUSION CONTROL

   Actualisering apparaatsoftware en aanbevolen dringende maatregelen betreffende WO300 OR1 FUSION CONTROL® .

   Waarschuwing | 29-09-2020

9. ThermoFisher Scientific-Microbiology Central Reporting, FSN-FSN-2020-0007, ThermoScientificTM OxoidTM F100 Nitrofurantoin

   A technical investigation has confirmed that some packs of Thermo Scientific™ Oxoid™ F100 Nitrofurantoin CT0034B Lot 2961028 may ...

   Waarschuwing | 08-09-2020

10. Hologic Inc., FSN-CTB-00753, Panther Fusion Tube Tray

    This notification is to inform you of a voluntary recall for Panther Fusion Tube Trays. These lots of tube trays have a very low ...

    Waarschuwing | 13-08-2020