Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Autonomic Technologies - Pulsante SPG Microstimulator System

   A change was made to the Pulsante® SPG Microstimulator (the implantable component) which was not properly validated. This change ...

   Waarschuwing | 07-04-2017

2. Field Safety Notice: Abbott Vascular - Absorb (GT1) Bioresorbable Vascular Scaffold

   In samenwerking met de Europese regelgevende agentschappen (bevoegde autoriteiten en onze aangemelde keuringsinstantie (notified ...

   Waarschuwing | 31-03-2017

3. Field Safety Notice: Optimed - sinus-SuperFlex-635

   The details of the label on the packaging do not correspond to the delivered product. The information of the inner label on the ...

   Waarschuwing | 31-03-2017

4. Field Safety Notice: Aesculap - Diamond burr with coarse and extra-coarse grain

   With this letter, we would like to inform you that Aesculap AG is initiating a global voluntary product recall of diamond burrs ...

   Waarschuwing | 27-03-2017

5. Field Safety Notice: Intuitive Surgical, vrijgavekit voor de da Vinci® Xi EndoWrist Stapler

   Intuitive Surgical heeft klachten ontvangen dat het instrument tijdens gebruik is gebroken. Fabrikant: Intuitive Surgical ...

   Waarschuwing | 23-03-2017

6. Field Safety Notice: Cook - Zenith Alpha™ Thoracale Endovasculaire prothese

   Middels deze veiligheidskennisgeving willen wij uw aandacht vestigen op een aantal aspecten van de nieuwe versie van de ...

   Waarschuwing | 22-03-2017

7. Field Safety Notice: ArcRoyal - Custom Procedure Trays Containing BD Plastipak 100 ml Syringe 10-005358

   The field safety notice has been initiated as syringes showed leakage past the stopper during routine real time stability tests, ...

   Waarschuwing | 07-03-2017

8. Field Safety Notice: Aesculap - MINOP INVENT 30° TROCAR, FH620R

   We were informed that the insulation of an electrode has been damaged intraoperatively when pulling it out of the MINOP INVENT ...

   Waarschuwing | 06-03-2017

9. Field Safety Notice: Advanced Medical Solutions, LiquiBand FIX8

   AMS will be temporarily removing revision 03 of the Instrucions for Use (IFU) from use and reintroducing revision 01. Fabrikant: ...

   Waarschuwing | 03-03-2017

10. Field Safety Notice: CONMED Corporation, Hyfrecator® 2000 Electrosurgical Units

    From December 2, 2015 to January 3, 2017, the Accessory Packages in the Hyfrecator® 2000 ESU cartons were packaged in error by ...

    Waarschuwing | 28-02-2017