Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Jafron Biomedical Co., FSN-2021-001, Disposable Hemoperfusion Cartridge (HA)

   Probleem: [Beoogd gebruik] in de producthandleiding van HA wordt het beschreven als het verwijderen van de endogene en exogene ...

   Waarschuwing | 22-10-2021

2. Medtronic FA968 - Activa Clinician Programmer Application - Update July 2021

   Dit is een vervolgbericht om u te informeren dat nu een nieuwe versie van de artsenprogrammeerapp model A610 beschikbaar is om de ...

   Waarschuwing | 30-07-2021

3. Medtronic FA969 - Activa Clinician Programmer Application - Update July 2021

   Dit is een vervolgbericht om u te informeren dat nu een nieuwe versie van de artsenprogrammeerapp model A610 beschikbaar is om de ...

   Waarschuwing | 30-07-2021

4. Baxter Healthcare SA, FSN-FA-2020-065, PRISMAX, V2 ROW

   Baxter Healthcare Corporation is issuing a Device Correction for the PrisMax System due to inconsistent variability of the tubing ...

   Waarschuwing | 11-01-2021

5. Baxter Healthcare SA, FSN-FA-2020-064, PrisMax, V2, ROW

   Baxter Healthcare is issuing a Safety Alert for the PrisMax System.

   Waarschuwing | 11-01-2021

6. Nipro India Corporation FSCA 20201030 - Elisio-H and Elisio-M dialyzers

   Nipro India Corporation (NIC) has identified an issue that, in specific lot numbers of product codes ELI-21H-PO-GIN and ...

   Waarschuwing | 30-10-2020

7. Baxter FA-2020-006 - Prismaflex Control Unit

   Baxter is communicating important safety information regarding the use of connectors with the Prismaflex system. The use of ...

   Waarschuwing | 19-02-2020

8. GAMBRO DASCO, FA-2019-055, Artiset HD DNL HC; Artset pre-post

   Baxter Healthcare Corporation is issuing a voluntary product recall for the ArtiSet Blood Tubing Sets listed below due to the ...

   Waarschuwing | 28-10-2019

9. Baxter Healthcare, FA-2019-041, PrisMax V2 ROW

   Baxter Healthcare has identified the potential for certain PrisMax devices to develop cracks in the blood pump raceway over time ...

   Waarschuwing | 19-08-2019

10. Olympus, QIL 152-002, EVIS EXERA(Q190V)-/LUCERA(Q290V) DUODENOVIDEOSCOPE

    Our early warning system has recently signaled an increase in the number of complaints from customers who noticed air leakage ...

    Waarschuwing | 10-05-2019