Events

Avis De Sécurité sur cobas c 501 module, cobas c 502 module

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
    2017-07-11
  • 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 an operator was injured during a maintenance task, when removing the ultrasonic mixer cover (usm cover 3) of a cobas c 502 module. considering that cobas c 501 and cobas c 502 modules share the same hardware, roche diagnostics has decided to inform and request operators of both systems to perform the related maintenance task with special caution, so as to prevent further occurrence of this issue. when the operator cleans the incubation bath or replaces cuvettes on cobas c 501 and cobas c 502 modules, during monthly maintenance, the usm cover 3 has to be removed and its two thumb screws have to be loosened. .

Device

cobas c 501 module, cobas c 502 module

Manufacturer

Roche Diagnostics