Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Micro Therapeutics Inc. DBA ev3 Neurovascular, FSN-FA929, PipelineTM Flex Embolization Device (with Shield TechnologyTM)

   Medtronic is providing this notice regarding a labeling update to ensure awareness among Pipeline™ Flex and Pipeline™ Flex with ...

   Waarschuwing | 02-09-2020

2. The Magstim Company Ltd, FSN-FCA-2020-02, Neurosign V4

   Magstim are issuing a voluntary corrective action following reports that manipulation of the cable which connects the ...

   Waarschuwing | 01-07-2020

3. Elekta Instrument AB, FCA-EIAB-0008, Leksell Vantage Arc System

   Elekta has found that the design of the Instrument Carrier is not optimal which may cause the locking mechanism at the interface ...

   Waarschuwing | 08-06-2020

4. Medtronic Inc FA912 Verify Therapy App

   This letter is to notify you of the correction of an inadvertent automatic update to Model A511 Clinician Therapy Application ...

   Waarschuwing | 22-04-2020

5. The Spectranetics Corporation D055703 Bridge® Occlusion Balloon

   The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...

   Waarschuwing | 26-03-2020

6. Medtronic FA906 - Pipeline Flex Embolization Device

   Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of ...

   Waarschuwing | 27-02-2020

7. Medtronic Inc. FA889 SynchroMed® II Implantable Infusion Pump

   Bij een permanente motorstop zal de medicamenteuze infusietherapie stoppen, wat kan leiden tot terugkeer van onderliggende ...

   Waarschuwing | 01-10-2019

8. LivaNova USA, Inc., NM-HOU-2019-002 VNS Therapy® SenTiva® Generator

   Unintended device disablement may occur in a small population of Model 1000 generators (Serial Numbers ≥ 100,000) due to a ...

   Waarschuwing | 26-09-2019

9. Natus Medical Denmark DOC-035720 Chartr EP 200

   It has been determined that the device does not fully meet current regulatory standard for basic electrical safety and essential ...

   Waarschuwing | 31-07-2019

10. Microtek Medical Ltd. ECL-FSCA-138 - Intraoperative Probe Cover with Long Surgi-Tip

    Er is een zeer kleine kans op bacteriële contaminatie van een aantal batches van de intra-operatieve sondehoes. Ecolab heeft ...

    Waarschuwing | 19-07-2019