Events

Alerta De Seguridad para TempSpan CMT

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

¿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
    2013-01-23
  • Fecha de publicación del evento
    2013-01-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130123.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: sybron dental specialties tempspan cmt medical device manufacturer, sybron dental specialties, inc., has issued a customer notification concerning all production lots within shelf life of tempspan cmt. the affected part numbers are n69ca and n69cs. the manufacturer is conducting a voluntary recall of tempspan cmt production lots that were shipped to customers since january 2011 because they may exhibit work time fluctuations and work faster than what the dfu advises. although there are no safety or efficacy issues associated with this product according to the manufacturer, product recall is ongoing. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 january 2013.

Device

TempSpan CMT
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Sybron Dental Specialties TempSpan CMT
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties