Alerta De Seguridad para Electrical Lift Table

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

¿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
    2015-11-27
  • Fecha de publicación del evento
    2015-11-27
  • País del evento
  • Fuente del evento
    DH
  • 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: iba dosimetry gmbh electrical lift table medical device manufacturer, iba dosimetry gmbh, has issued a medical device safety alert concerning its electrical lift table [part number: ha03-000#002, ha03-010#002]. the manufacturer has identified a potential safety issue that may affect the performance of the electrical lift table under certain circumstances. when the lifting table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner. due to the forces involved, a person trying to stop the lifting table can be seriously injured. to prevent this error from occurring, users should follow the instruction in the section below until the problem is completely resolved. the manufacturer instructs affected users to take the following actions:- before receiving the replacement part: disconnect the mains power connection of the electrical lift table after setting up the table and blue phantom2. the table must not be connected to the mains power when its electrical functions are not in use for alignment. after receiving the replacement part: a new hand control including its cable will be sent when it is ready. the replacement instruction will be included in the shipment. users should immediately replace the original one upon receiving the shipment. according to the manufacturer, 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 27 november 2015.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: IBA Dosimetry GmbH Electrical Lift Table
  • Manufacturer

Manufacturer