Events

Alerta De Seguridad para Practix Convenio Mobile X-ray System

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

¿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
    2012-05-31
  • Fecha de publicación del evento
    2012-05-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120531.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: philips practix convenio mobile x-ray system medical device manufacturer, philips medical systems issued a safety alert concerning practix convenio mobile x-ray system with serial number pc1-0504 through pc1-0588. philips warned that when the affected systems are switched off or when the tube arm is parked into its designated parking position (x-ray generator switch off), a radiation pulse (50 kv, 2.5 μgy) is inadvertently generated. this occurs on a small number of systems with a particular electronic component on the controller board. according to philips, there is a potential that the radiation from this extra x-ray pulse might reach a person in the vicinity of the system, resulting in unintended exposure. this extra radiation may also cause artifacts on x-ray images, if a cassette was in the path of the radiation. philips supplemented that the controller board of the affected systems will be updated later. meanwhile, the affected users are advised to completely close the shutters of the collimator before switching off the system and before bringing the tube assembly to its parking position. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 31 may 2012.

Device

Practix Convenio Mobile X-ray System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Practix Convenio Mobile X-ray System
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH