Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. GAMBRO DASCO, FSN-FA-2020-068, Haemodialysis tubing set single-use

   Baxter Healthcare Corporation has received customer reports of kinked access lines observed during treatment using cartridge sets ...

   Waarschuwing | 06-01-2021

2. Medtronic Inc., FSN-FA949, Intellis Clinician Programmer Application

   Medtronic vaardigt vrijwillig een dringende veiligheidskennisgeving uit om te verzoeken dat u de Intellis™-softwaretoepassing ...

   Waarschuwing | 18-12-2020

3. Medtronic, Inc., FSN-FA948, ARESTM Antibiotic-Impregnated Catheter

   Medtronic roept vrijwillig specifieke partijen ARES™ met antibiotica geïmpregneerde shuntkatheters terug.

   Waarschuwing | 10-12-2020

4. Boston Scientific 92629317-FA - (Hot) AXIOS-stent en -plaatsingssysteem met elektrocauterisatiefunctie

   Boston Scientific Corporation (BSC) haalt bepaalde partijen/batches van de AXIOS-stent en -plaatsingssysteem met ...

   Waarschuwing | 01-12-2020

5. NIPRO INDIA CORPORATION PVT LTD, FSN-FSCA 20201112, Hemodialyzers

   Urgente veiligheidsmededeling Voorraad vasthouden van specifieke partijnummers van de kunstnieren ELISIO™-H en ELISIO™-M.

   Waarschuwing | 25-11-2020

6. Olympus Medical Systems Corporation, FSN-QIL 153-012, Several GF-EUS ultrasound endoscopes

   Olympus is writing to inform you of a Field Safety Corrective Action for the Olympus Endoscopic Ultrasound Endoscopes (‘EUS’).

   Waarschuwing | 17-11-2020

7. Gambro Dasco, FSN-FA-2020-047, Artis Evosys Integra Innova

   Baxter is communicating important safety information regarding the use of connectors between the patient’s blood access device ...

   Waarschuwing | 17-11-2020

8. Mevion Medical Systems Inc, FSN-FSCA_201103, MEVION S250i Proton Therapy System

   Auto-Field Sequence workflow fails to prevent treatment after isocenter is lost during setup.

   Waarschuwing | 06-11-2020

9. GA Health Company Limited, FSN-QA-FSCA-2020-0001, Andorate® / PEXTAX Disposable Endoscope Valves Set (GAR004)

   GA Health Company Ltd. became aware that suction valve from Andorate® disposable endoscope valves set was sticky and/or broken ...

   Waarschuwing | 06-11-2020

10. 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