Events

Alerte De Sécurité sur All ZeniPower Mercury-free Hearing Aid Batteries

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par ZeniPower Battery Company Limited.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-03-11
  • Date de publication de l'événement
    2016-03-11
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160311.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: all zenipower mercury-free hearing aid batteries the medicines and healthcare products regulatory agency (mhra) of the united kingdom has issued an alert concerning all zenipower mercury-free hearing aid batteries manufactured by zenipower battery company limited. the affected product code numbers are as follows: a675p mf – r44 zinc air size 675 for cochlear implants a675 mf – r44 zinc air size 675 a13 mf – r48 zinc air size 13 a312 mf – r41 zinc air size 312 a10 mf – r70 zinc air size 10 [only batteries with best before dates of ‘08-2018’ and ‘09-2018’ are affected] according to the mhra, the problem is caused by excessive gassing, as the zinc electrode reacts with the electrolyte to generate hydrogen. the battery may expand and possibly explode on rare occasions. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/all-zenipower-mercury-free-hearing-aid-batteries-low-risk-of-batteries-exploding-during-use-or-if-depleted if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 march 2016.

Device

All ZeniPower Mercury-free Hearing Aid Batteries
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: All ZeniPower Mercury-free Hearing Aid Batteries
  • Manufacturer
    ZeniPower Battery Company Limited

Manufacturer

ZeniPower Battery Company Limited
  • Source
    DH