Events

Alerta De Seguridad para Virtua / Virtua XR Medical Disc Publisher

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

¿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
    2016-10-25
  • Fecha de publicación del evento
    2016-10-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161025b.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: codonics virtua / virtua xr medical disc publisher medical device manufacturer, codonics, has issued a field safety notice concerning its virtua / virtua xr medical disc publisher [serial number: prefix of “83”]. the manufacturer has identified an issue with the sata power connector on these systems that have the potential to overheat and fail. according to the manufacturer, overheating may result in a noticeable smell and possibly smoke. the cause of the failure is a defective cable and inadequate cable support. the users are instructed to immediately power off and unplug affected systems until a replacement cable can be installed. units must be properly powered down to ensure the print head is parked. replacement cables are being manufactured and the initial shipments and instructions will be provided to the distributors and repair centers at no cost. 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 25 october 2016.

Device

Virtua / Virtua XR Medical Disc Publisher
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Codonics Virtua / Virtua XR Medical Disc Publisher
  • Manufacturer
    Codonics

Manufacturer

Codonics