Events

Alerta De Seguridad para Wallach LL100 Cryosurgical System

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

¿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
    2015-03-25
  • Fecha de publicación del evento
    2015-03-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150325.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: coopersurgical wallach ll100 cryosurgical system medical device safety alert: coopersurgical wallach ll100 cryosurgical system the manufacturer’s internal quality assurance programme has determined that one of the internal gas lines may malfunction causing the line to burst under pressure. according to the manufacturer, the potential hazard associated with the failure mode is negligible; there is no foreseen adverse event due to this failure mode. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 march 2015.

Device

Wallach LL100 Cryosurgical System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: CooperSurgical Wallach LL100 Cryosurgical System
  • Manufacturer
    CooperVision

Manufacturer

CooperVision