Events

Alerte Ou Avis De Sécurité sur Aquilon series of nebulisers

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par AFP Medical.

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
    Safety alert / Field Safety Notice
  • Date
    2018-02-22
  • Date de publication de l'événement
    2018-02-22
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/aquilon-series-of-nebulisers-ce-mark-withdrawn-and-supply-ceased
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    Following withdrawal of the CE mark for the Aquilon series of nebulisers, the manufacturer (AFP Medical) has continued to place the nebulisers on the market.The nebuliser and packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
  • Cause
    Manufactured by afp medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (mda/2018/008).
  • Action
    Identify affected devices from the list below. Identify patients and relevant healthcare professionals and advise them to: stop using and dispose of the nebulisers use an alternative nebuliser where available Patients who have any concerns should contact their GP or other healthcare professionalAction by:All medical, nursing and technical staff involved in the use and maintenance of these devices.

Device

Aquilon series of nebulisers
  • Modèle / numéro de série
  • Description du dispositif
    Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series manufactured since 01 April 2015 are affected.
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    MHRA