Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par GE Healthcare.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 046 02 18 000
  • Date de mise en oeuvre de l'événement
    2018-02-13
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12122
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. under these conditions, ge recommends the use of a sterile sheath covering the tee probe in addition to disinfection using the soak based disinfecting method or the tristel trio wipes system as described below.(see attached fsn).

Device

GE TEE probes used with Tristel Trio Wipes System
  • Modèle / numéro de série
    GE TEE probes used with Tristel Trio Wipes System The following TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS. (See Attached FSN for full details)
  • Description du dispositif
    Transducer assembly
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare