Alerta De Seguridad para Akron Tilt Table

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

¿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: arjohuntleigh akron tilt table medical device manufacturer, arjohuntleigh, has issued a medical device safety alert concerning its akron tilt table [model number: a8652, a8652t; serial number: between p0167499 and p0418644]. the manufacturer received a customer complaint related with akron tilt table middle section frame breakage in its post-market surveillance monitoring. the investigation showed that one of critical welds in the part was missing. there was no injury related to this incident. according to the manufacturer, the issue is related with potential hazard for patients and if the affected device will be used it can lead to collapse during movement to the vertical position. in the worst case, scenario user can fall down with the upholstery (if not protected with belts). the manufacturer will arrange a service technician to visit the facilities to carry out welds presence verification and the frame replacement if a missing weld/missing welds would be detected. it is not recommended to use the couch until action would be taken by the manufacturer. the affected customers are instructed to ensure that all caregivers and users of the affected devices are made aware of the field safety notice and all listed devices at their facilities are available to be corrected during service technician visit. 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 23 may 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: ArjoHuntleigh Akron Tilt Table
  • Manufacturer