Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. GE Healthcare Finland Oy - FMI 39001 - ECG trunk cables, ECG Leadwires

   ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting ...

   Waarschuwing | 27-06-2019

2. Teleflex Medical - EIF-000362 - Arterial Catheterization Set

   Arrow International is voluntarily issuing a Field Safety Notice for these products as they may contain the incorrect IFU, which ...

   Waarschuwing | 25-06-2019

3. Becton Dickinson, MDS-19-1516, BD PhaSeal™ C61 Secondary Set

   Het product wordt teruggeroepen vanwege mogelijke lekkage bij de verbinding tussen de leiding en de spike.

   Waarschuwing | 09-05-2019

4. Maquet, Cardiosave Hybrid Rescue Intra-Aortic Balloon Pump

   Dit probleem kan leiden tot een onderbreking en/of onvermogen om de behandeling van de patiënt te starten vóór of tijdens het ...

   Waarschuwing | 12-10-2018

5. W.L. Gore 15Oct17 - Conformable GORE® TAG® Thoracic Endoprosthesis

   Onvolledige en/of gedeeltelijke ontplooiing van de vormbare GORE® TAG® thoracale endoprothese (het vormbare TAG®-hulpmiddel) ...

   Waarschuwing | 15-10-2017

6. Field Safety Notice: Boston Scientific - Jetstream Atherectomy Catheters

   Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm ...

   Waarschuwing | 06-04-2017

7. Boston Scientific 100000038229 - INGEVITY™ MRI pace,sense lead

   This letter provides important product performance information regarding a population of fifteen (15) Boston Scientific INGEVITY™ ...

   Waarschuwing | 02-12-2016

8. Field Safety Notice: Navilyst Medical - Xcela en BioFlo PICC

   Greatbatch Medical heeft vastgesteld dat de handgrepen van de producten in hun terugroepkennisgeving van 11 november 2016 tijdens ...

   Waarschuwing | 30-11-2016

9. B.Braun Melsungen AG 400323085 - SeQuent Please PTCA Katheter 2,5 x 15 mm

   As an appropriate corrective action a recall of the designated article 5022220 batch number 16E02809 was decided and implemented. ...

   Waarschuwing | 23-11-2016

10. Vascular Solutions 2134812-09.20.2016-002R - Twin-Pass, Twin-Pass .023", and Twin-Pass RX Dual Access Catheters

    Upon investigation of Twin-Pass units, it’s been concluded there is a potential for excess manufacturing material to remain at ...

    Waarschuwing | 23-09-2016