Events

Avis De Sécurité sur VITROS® 5600 Integrated Systems

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 Ortho Clinical 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
  • 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
    The electrical wires are located in an area that is intended to be accessed only by an ortho-trained service representative. normal use, maintenance and troubleshooting on your vitros® 5600 system will not expose an operator to electrical hazards as a result of this issue. if a system has the incorrect wire configuration, it is possible that if the power to an individual module is intended to be shut off, it will remain on. however, there is no risk to ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the vitros® 5600 system as a whole prior to working on a component. .

Device

VITROS® 5600 Integrated Systems
  • Modèle / numéro de série
    VITROS® 5600 Integrated System 6802413 6802915 10758750002740 10758750007110
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics