Events

Alerta De Seguridad para OEC 9900 systems

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

¿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
    2014-07-21
  • Fecha de publicación del evento
    2014-07-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140721a.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: ge healthcare oec 9900 systems medical device manufacturer, ge healthcare, has issued a field safety notice (fsn) concerning oec 9900 systems manufactured between 9 oct 2013 and 9 jun 2014, and oec 9900 systems that had an extension arm replaced between 9 oct 2013 and 9 jun 2014. the manufacturer issued an urgent medical device correction notice in earlier 2014 regarding a monitor arm screw issue. the screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to tilt or fall forward. based on further investigation, the manufacturer is taking additional actions to correct the screws that attached the workstation monitor spring arm. the manufacturer advises users of the followings: use caution when positioning or extending the workstation articulating arm. refrain from positioning staff or patients directly underneath or in front of a workstation monitor. the manufacturer’s local field engineer will contact users to coordinate the replacement of the screws, and ensure that the system meets specifications. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 july 2014.

Device

OEC 9900 systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare OEC 9900 systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare