Events

Alerta De Seguridad para Leica tissue processor

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Leica Biosystems Nussloch 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
  • ID del evento
    I1509-456
  • Número del evento
    2014DM-0012120
  • Fecha
    2015-09-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer establishes that the internal wiring of the remote alarm plug in the referenced medical devices may be incorrect, which may cause the remote control not to work properly in case of failure of the instrument, the loss of the alarm could lead to improper processing of the shows, which could lead to re-interventions and potential adverse events on the patient.

Device

Leica tissue processor
  • Modelo / Serial
    ASP200 and ASP300S, with serials 5259, 5260, 5264, 5266, 5267, 5272, 5273, 5289, 5301, 5310, 5348, 5349, 5356, || 5366, 5381, 5385, 5386, 5387, 5388, 5398, 5401, 5403, || 5407, 5416, 5426, 5434, 5435, 5446, 5530, 5562, 5609, || 5610, 5612, 5663, 5670, 5673, 5682, 5693, 5706, 5724, || 5725, 5734, 5737, 5794, 5796, 5798, 5799, 5804, 5807, || 5815, 5871, 5873, 5874, 5875, 5886, 5889, 5909, 5926, || 5929, 5946, 5947, 5948, 5955, 5956, 5962, 5965, 5977, || 6000, 6015, 6021, 6040, 6041, 6042, 6045, 6046, 6062, || 6115, 6131, 6149
  • Descripción del producto
    Only qualified personnel should use the tissue processor. The equipment has been designed in such a way that it is fault-proof - both in terms of the user and the samples to be processed - provided that the user complies at all times with the instructions in the user manual. The equipment has been designed for the following laboratory applications: • fixation, • dehydration, • paraffin infiltration of histological samples.
  • Manufacturer
    Leica Biosystems Nussloch Gmbh

Manufacturer

Leica Biosystems Nussloch Gmbh