Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Siemens Healthcare Diagnostics Products, Dimension Vista® CER Flex® Reagent

   Siemens Healthineers has confirmed a negative bias of approximately -20% for results obtained with Dimension Vista® CER Flex® ...

   Waarschuwing | 09-06-2017

2. Field Safety Notice: Siemens Healthcare Diagnostics, ADVIA Centaur® -XP® -XPT®

   Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ...

   Waarschuwing | 09-06-2017

3. Field Safety Notice: Baxter Healthcare SA, CLARIA SHARESOURCE PLATFORM

   Over the weekend of May 27, 2017, a planned maintenance of the Sharesource application resulted in three unintended effects:... ...

   Waarschuwing | 09-06-2017

4. Medline International France SAS, FSN-17/04, oogheelkundige steriele klantensets

   De naalden 25G oranje in de onderstaande sets (vermeld in lijst 1 van ontvangstbevestiging) hebben een lengte van 2 cm, voorheen ...

   Waarschuwing | 08-06-2017

5. Field Safety Notice: Haemonetics S.A., Cell Saver Elite

   Bij sommige centrifugebowls in deze sets veroorzaakt de buitendiameter aan de onderkant van de bowl problemen wanneer de bowl in ...

   Waarschuwing | 08-06-2017

6. Field Safety Notice: Getinge/Maquet, Atrium Advanta V12 Balloon Expandable Covered Stent

   This field notification addresses a labeling problem on devices listed above, in which the device manifold (or catheter hub) may ...

   Waarschuwing | 07-06-2017

7. Field Safety Notice: Abbott - Thoratec Corporation, HeartMate 3™ (steunhart)

   We hebben vastgesteld dat er een mogelijkheid bestaat van een communicatiefout tussen de systeembediening van de patiënt en het ...

   Waarschuwing | 07-06-2017

8. Field Safety Notice: Hitachi, Ltd., Arietta Prologue

   Operation of Arietta Prologue becomes unstable due to contact failure between backend unit (BE, screen side) and frontend unit ...

   Waarschuwing | 07-06-2017

9. Field Safety Notice: Zimmer Biomet, Various Trauma & Extremity Instruments (Drill bits and Screw taps)

   The anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. Accordingly, all ...

   Waarschuwing | 07-06-2017

10. Field Safety Notice: ARJOHUNTLEIGH, FLOWTRON ACS900

    It has been identified that in some instances the pump will constantly deliver pressure to the garment without triggering the ...

    Waarschuwing | 06-06-2017