Events

Alerte Ou Avis De Sécurité sur Non CE-marked portable dental X-ray units

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 Zhengzhou Tianjie Electronic Equipment Co.

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
  • ID de l'événement
    MDA/2012/046
  • Numéro de l'événement
    CON173752
  • Date
    2012-07-16
  • Date de publication de l'événement
    2012-07-16
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON173752?tabName=allTabs
  • 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
  • Cause
    Testing by the health protection agency (hpa) has revealed that the tianjie dental falcon device lacks sufficient shielding in the x-ray tube, which could give rise to high patient doses and under typical high radiographic workloads result in operator doses in excess of the ionising radiation regulations 1999 annual dose limits. this could give rise to adverse health effects caused by radiation. the tianjie dental falcon is not ce-marked as a medical device.
  • Action
    Identify and stop using this and similar non CE-marked devices. Replace the device with a suitable CE-marked alternative. Be aware of the NRPB (HPA) Guidance Notes for Dental Practitioners on the Safe Use of X-Ray Equipment or the Medical & Dental Guidance Notes published by IPEM. Be aware of the general requirement to consult a suitable radiation protection adviser with regard to the use of X-ray equipment. Be aware of MHRA advice on the use of non-CE marked devices. Report any suspected devices to MHRA Adverse Incident Centre.

Device

Non CE-marked portable dental X-ray units
  • Modèle / numéro de série
  • Description du dispositif
    Non CE-marked portable dental X-ray units. Including the Tianjie Dental ‘Falcon’. The Tianjie Dental Falcon portable X-ray unit is not CE-marked as a medical device and was purchased on eBay. It is identical in appearance to a number of other non CE-marked devices that are available on the internet:
  • Manufacturer
    Zhengzhou Tianjie Electronic Equipment Co

Manufacturer

Zhengzhou Tianjie Electronic Equipment Co
  • Source
    MHRA