Events

Alerta De Seguridad para Medrad Spectris Solaris EP MR Injection System

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

¿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
    2017-01-26
  • Fecha de publicación del evento
    2017-01-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170126.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: bayer medical care medrad spectris solaris ep mr injection system medical device manufacturer, bayer medical care, has issued a medical device safety alert concerning its medrad spectris solaris ep mr injection system [catalogue number: 3012011; serial number: 202052]. the manufacturer has determined that the battery/cable power assemblies in spectris solaris ep mr injection systems (ssep) distributed from september – november 2016 do not meet the specifications. this could result in intermittent power failure of the device which could result in a degraded image or a delay of the imaging procedure requiring a repeat of the contrast-enhanced mr scan should it occur during a procedure. the manufacturer will replace the battery/cable power assembly for the affected users. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 january 2017.

Device

Medrad Spectris Solaris EP MR Injection System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bayer Medical Care Medrad Spectris Solaris EP MR Injection System
  • Manufacturer
    Bayer Medical Care

Manufacturer

Bayer Medical Care
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DH