Events

Alerta De Seguridad para Alaris PC unit model 8015 with software version 9.12

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

¿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
    2013-04-26
  • Fecha de publicación del evento
    2013-04-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426d.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: carefusion alaris pc unit model 8015 with software version 9.12 the united states food and drug administration (fda) has posted a medical device safety alert issued by medical device manufacturer, carefusion corporation, concerning its alaris pc unit model 8015 with software version 9.12. according to the manufacturer, the recall was initiated because the manufacturer has received reports of a communication error on the alaris pc unit model 8015 with software version 9.12 when the alaris etco2 module or alaris spo2 module is attached. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm? action=select&recall_number=z-1098-2013&w=04242013&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

Alaris PC unit model 8015 with software version 9.12

Manufacturer

Carefusion Corporation