Events

Rappel de Pro BP Handheld BP Device

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Welch Allyn Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    21735
  • Date de mise en oeuvre de l'événement
    2017-07-28
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • Cause
    The manufacturer has been made aware of an issue which could potentially affect the probp 2400 digital blood pressure. as a result of a defective electrical component in the battery charging circuit, when the probp 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. this potential defect resides with the device, not the battery. the over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.
  • Action
    Product to be exchanged

Device

Pro BP Handheld BP Device
  • Modèle / numéro de série
    Model: , Affected: Serial Numbers (21)12150001 - (21)12150500
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc