Events

Avis De Sécurité sur Baby Beets Fetal Doppler

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par N/A.

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
  • Numéro de l'événement
    SN2008(03)
  • Date
    2008-02-01
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/baby-beets-fetal-doppler&id=d693f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The irish medicines board (imb) have been alerted that the ‘baby beets fetal doppler’ is not officially ce marked and therefore may not reach the required standards of safety and quality, as required by the medical device legislation.  this product may have been purchased through the internet.
  • Action
    Check if you have a Baby Beets Fetal Doppler in your possession.   If you have determined that you have this product, you should discontinue use immediately.   If you have any health concerns, please consult your doctor (General Practitioner, Gynaecologist or Obstetrician) for their advice.   If you are selling this product, stop, quarantine the product and contact the IMB immediately.

Device

Baby Beets Fetal Doppler
  • Modèle / numéro de série
  • Description du dispositif
    Baby Beets Fetal Doppler
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA