Events

Avis De Sécurité sur cobas 8000 core unit

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 Roche 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
    2017-07-20
  • 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
    We regret to inform you that we have identified a software limitation, which in rare cases resets your system configuration of the control unit software to default. roche diagnostics received 6 complaints in total regarding this issue. the control unit (cu) settings under utility-system are reset to the default settings, under the following conditions: 1. the date and time in the status line of the user interface is not displayed 2. the information about the “analytical unit” (au) is not displayed in the data review screen (however, it is still displayed in the test review screen) 3. the year/month/date/time of the printout preview on the history screen is not displayed .

Device

cobas 8000 core unit

Manufacturer

Roche Diagnostics