Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Medtronic Inc. FA984 - Vectris SureScan MRI Lead kit

   Medtronic heeft vastgesteld dat specifieke PIN's van de Vectris SureScan MRI-geleidingsdraadsets onjuiste informatie bevatten ...

   Waarschuwing | 09-07-2021

2. Field Safety Notice: Autonomic Technologies - Pulsante SPG Microstimulator System

   A change was made to the Pulsante® SPG Microstimulator (the implantable component) which was not properly validated. This change ...

   Waarschuwing | 07-04-2017

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. Field Safety Notice: BALT Extrusion, microcatheter SONIC 1.5 F

   Krachtens de beslissing genomen door de bevoegde Franse autoriteit ANSM onderbreekt BALT Extrusion de vervaardiging, de verkoop, ...

   Waarschuwing | 28-04-2017

5. Synovis Micro Companies Alliance, Inc., FA-2023-015, Neurotube 02X40 RP CE

   Baxter Healthcare Corporation is issuing a Recall to the user level for the NEUROTUBE Lot number 19012112 due to the product ...

   Waarschuwing | 19-04-2023

6. Medtronic, FA1324, Neuroscience CST StealthStation S7 Cranial Software v3.1.4

   Medtronic identified two software anomalies in StealthStation™ Cranial Version 3.1.4 software that can occur under specific ...

   Waarschuwing | 21-12-2023

7. Medtronic Inc., FA1266, Vanta™ Clinician Programmer Application CP App A71200 v2.0.2455

   As previously communicated by Medtronic, in July 2022, in these rare occurrences during initial programming, the Vanta CP App ...

   Waarschuwing | 19-01-2023

8. Medtronic Inc., FSN-FA1266, Vanta LT Clinician Programmer Application

   In deze zeldzame gevallen geeft de Vanta™ AP-app tijdens de eerste programmering het bericht met foutcode 1502 weer omdat het ...

   Waarschuwing | 04-08-2022

9. Medtronic, FA1247, NIM Vital Nerve Monitoring System

   Failure to connect the ground electrode during case setup will incorrectly display a false passing ground impedance /electrode ...

   Waarschuwing | 17-06-2022

10. Technomed Europe CAPA 21-009_NCR 21-081 - Disposable Subdermal Needle Electrode, corkscrew

    Technomed is issuing a Medical Device Recall notice following the observation of a high risk that the needle electrode could ...

    Waarschuwing | 23-12-2021