Events

Alerta De Seguridad para All ZeniPower Mercury-free Hearing Aid Batteries

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por ZeniPower Battery Company Limited.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-03-11
  • Fecha de publicación del evento
    2016-03-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160311.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: All ZeniPower Mercury-free Hearing Aid Batteries
  • Manufacturer
    ZeniPower Battery Company Limited

Manufacturer

ZeniPower Battery Company Limited
  • Source
    DH