Events

Avis De Sécurité sur Integrated Cycler System USB Cable Assembly 2M Ferrite

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Focus Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2015-11-24
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Focus determined that the ics was not in compliance with a recently revised electromagnetic compatibility standard (emc), en 61326-12013, that is noted in the integrated cycler studio operator manual, preface — health and safety information (page xiii). for the ics to be in compliance with the current emc standard, focus will provide the usb cable assembly 2m ferrite to replace the existing usb cable. focus conducted tests to ensure the new usb cable assembly 2m ferrite meets the requirements of the revised emc standard.

Device

Integrated Cycler System USB Cable Assembly 2M Ferrite

Manufacturer

Focus Diagnostics