Events

Alerta De Seguridad para adac argus gamma camera systems

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

¿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
    2013-11-11
  • Fecha de publicación del evento
    2013-11-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131111.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 adac argus gamma camera systems the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning adac argus gamma camera systems manufactured by philips medical systems cleveland inc. products with serial numbers a01100227 and 9807143 are affected. a recent investigation has determined that visual inspections of the fork joints behind the detector that is conducted during six month preventive maintenance may not detect small cracks or deficiencies in the fork weldment. a failure in the fork weldment has the potential to cause the detector assembly to detach, resulting in serious injury or death to a patient, operator or service personnel member if he or she is in the direct path of the detector assembly when the weldment fails. philips is informing the customers to immediately cease the use of the affected systems. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01149-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2013.

Device

adac argus gamma camera systems

Manufacturer

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