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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

397 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Atrium Medical Corporation 3011175548-02/25/2022-001-C - Advanta V12 Covered Stent System

    Atrium/Getinge is initiating a voluntary Medical Device Field Correction for the Advanta V12 Covered Stent System due to an ...

    Waarschuwing | 15-03-2022

  2. LeMaitre Vascular, CAPA 2022-001-NL, AlboGraft Polyester Vascular Graft

    LeMaitre trekt bepaalde AlboGraft-apparaten terug en ruilt ze om vanwege een wijziging in de wettelijke status.

    Waarschuwing | 11-03-2022

  3. Draeger Medical Systems PR116042 - Infinity® CentralStation SW VG2.1.2(SU1)

    During the course of our global market surveillance activities, we have become aware of cases in which restarts of the lnfinity® ...

    Waarschuwing | 10-03-2022

  4. Philips Goldway (Shenzhen) Industrial Inc., FSN-FSCA 2021-CC-EC-019-IR, Philips HeartStart Intrepid Monitor/Defibrillator

    The HeartStart Intrepid 12-Lead ECG feature may lose the ECG signal when (a) it is connected to the patient and (b) the Right Leg ...

    Waarschuwing | 15-02-2022

  5. Pulsion Medical Systems FA574697 - PiCCO Monitoring Kit + ProAQT Sensor

    We have identified that the listed products have been produced with packaging material that is suspected to have an uncoated ...

    Waarschuwing | 14-02-2022

  6. HeartWare Inc., FSN-FA1226, HVAD™

    Instructions for Use and Patient Manual Updates – Cleaning of Controller Connector and Power Source Connector Pins. Specifically, ...

    Waarschuwing | 08-02-2022

  7. Huntleigh Healthcare Ltd, FSN-FSN01-22, Dopplex

    We have isolated the issue to one specific lot number (10)7842006001 where there is a possibility of the probe head becoming ...

    Waarschuwing | 07-02-2022

  8. Acandis GmbH FSCA 22-001 - DERIVO® 2 Embolisation Device

    We have received an increasing number of complaints from customers who have reported difficulty in delivery of devices through ...

    Waarschuwing | 26-01-2022

  9. MICROVENTION INC, FSN-FCA202105, HydroCoil Embolic System - HYDROSOFT 3D

    Meer specifiek wordt op het tweede van de vier verwijderbare etiketten tweemaal verwezen naar de “HydroCoil™ 10”, in plaats van ...

    Waarschuwing | 24-01-2022

  10. Oscor Inc., FSN-1035166-12/22/2021-01-R/22-002-CMDR, Destino Twist / Brand Name: Guidestar

    During use of the Affected Products, the colored hub cap and seal may disengage which could result in patient harm associated ...

    Waarschuwing | 20-01-2022

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