Events

Alerta De Seguridad para Process Systems Manager Software Version 2.02.02c

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

¿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
    2012-03-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120321c.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
    Field safety notice: roche process systems manager software version 2.02.02c the health canada issued a type i medical device recall concerning the process systems manager (psm) software version 2.02.02c [model no.: 4944607001] manufactured by roche diagnostics ltd. according to health canada, this recall is about issue with the psm software version 2.02.02c and higher that leads to an unintended change of patient demographics in the psm database which could affect the interpretation of results within the psm environment. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions.

Device

Process Systems Manager Software Version 2.02.02c
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Process Systems Manager Software Version 2.02.02c
  • Manufacturer
    Roche Diagnostics Ltd

Manufacturer

Roche Diagnostics Ltd