Events

Alerte De Sécurité sur CLINICAL CHEMISTRY SYSTEM DIMENSION RXL MAX - Registration nº 10345161632. Serial Numbers: Annex I - Distribution Map

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnóstics Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1762
  • Date
    2015-12-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The company informs that the absence of the safety cover can cause a risk of electric shock to the operator. This question does not affect patient outcomes.
  • Cause
    Siemens healthcare has identified that in some rms refrigeration compressors, safety cover may be missing, in the electrical termination block. exposure to electrical risk in the electrical termination block is located immediately behind the rms waste container.
  • Action
    Care should be taken when removing the waste container from the RMS module. Under no circumstances should you place your hands in the RMS cabinet beyond what is necessary to remove the waste container. If any flex cartridge drops out of the waste container, do not enter the RMS cabinet to remove it. In addition, the WARNING page posted within the Warning Message should be attached on the outside of each RMS cabinet the customer owns, serving as a temporary warning to all operators until the machines are inspected. Please note that only customers who own the RMS module (optional) will be subject to the field action (Code DI 16-01)

Device

CLINICAL CHEMISTRY SYSTEM DIMENSION RXL MAX - Registration nº 10345161632. Serial Numbers: Annex ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnóstics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA