Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Erbe Elektromedizin GmbH ESV-00-107373 - Pneumo-Kryosonde; flexibel

   From observations in the market we have determined that leakages can occur in the plug of flexible pneumo cryo probes for ...

   Waarschuwing | 03-07-2017

2. 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

3. Field Safety Notice: Pentax - PENTAX Medical ED- en FD-duodenoscopen

   Tijdens de productie van duodenoscopen (inclusief de hieronder genoemde duodenoscoop modellen van vergelijkbaar ontwerp), wordt ...

   Waarschuwing | 03-03-2017

4. 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

5. Verathon Medical FCAA-0004 - GLIDESCOPE® GVL 2 STAT

   Verathon Inc. has become aware that product labelled as GVL® size 2 Stat lot GC32825 was physically packaged with GVL® size 1 ...

   Waarschuwing | 01-03-2017

6. Intuitive Surgical Inc 2955842-07/14/16-010-R - IS4000 EndoWrist Stapler 45, IS4000 EndoWrist Stapler 30, IS4000 EndoWrist Stapler 30 Curved-Tip

   This recall follows from a field failure where the stapler remained clamped on tissue, even when the Stapler Release Kit was ...

   Waarschuwing | 03-11-2016

7. Covidien LLC Clearify Visualization 10/16 - Clearify Visualization System

   This Field Safety Corrective Action (FSCA) is being conducted due to the potential for compromise of the package resulting in a ...

   Waarschuwing | 07-10-2016

8. Coloplast FRALL-2015-1207 - ACA1xx & ACA2xx - VORTEK - Single Loop Ureteral Stent

   De vervanging van de Vortek® Ureterale stents met enkele lus wordt niet beschreven in de huidige gebruiksaanwijzing (Instruction ...

   Waarschuwing | 22-12-2015

9. Bayer SA-15-RAD-12 & SA-15-RAD-14 - MEDRAD IntegoTM PET Source Administration Sets

   Wij hebben geconstateerd dat bepaalde brontoedieningssets (SAS) die met het Medrad ® Intego PET-infusiesysteem worden gebruikt, ...

   Waarschuwing | 10-12-2015

10. Teleflex 1505‐06 - 551.31 Filtraflux + Softflex

    INMED are recalling the products referenced above as cracking may occur at the 15mm and 22mm ISO female connector. This would ...

    Waarschuwing | 08-12-2015