Alerta De Seguridad para EasyDiagnost (70642, 70643, 706030, 706031, and 706032)

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips 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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 easydiagnost medical device manufacturer, philips healthcare, has initiated a field safety corrective action for philips easydiagnost (70642, 70643, 706030, 706031, and 706032). only units that have had the inclination switch replaced during service are affected. according to the manufacturer, an inclination switch in the stand may have been mounted incorrectly during system service. there is a potential that a significant compression force could be exerted on a patient if, due to a combination of software and hardware errors, the inclination switch is not activated and the tilting movement is not immediately stopped. this severe squeezing has the potential to result in serious harm or injury. however, there is a very low probability that this combination of errors would occur. the manufacturer advised users to refer to the ifu for actions taken in preventing unintended compression by inserting the "compression stop" in the highest position. a field service engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly s/he will reinstall it properly. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips EasyDiagnost
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source