Events

Alerta De Seguridad para Drytec Tc-99m Generator Lot number 5666

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por GE 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
    2009-04-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20080502.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
    Press release
  • Causa
    Voluntary recall of device containing non-sterile radioactive material the department of health (dh) received notification from a medical device manufacturing company about its voluntary recall of a batch of radiodiagnostic device which has failed the sterility test. according to the company- uk ge healthcare, the involved batch was known as drytec tc-99m generator lot number 5666. there was a possibility of infection if the non-sterile product was injected into patients. the device is used to prepare radioactive material for injection to patients during radiodiagnostic procedures. information available showed that the affected lot had been used in tuen mun hospital and hong kong sanatorium and hospital. so far, no adverse effect associated with the use of device has been received by dh. the dh has informed the hospital authority, private hospitals, radiodiagnostic laboratories and medical professional associations about the recall and advised them to check for details with the company. dh will continue to monitor the situation and advise the public and health profession accordingly. ends/wednesday, april 23, 2008.

Device

Drytec Tc-99m Generator Lot number 5666
  • Modelo / Serial
  • Descripción del producto
    Press release: Voluntary recall of device containing non-sterile radioactive material
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare