Events

Alerta De Seguridad para BD MAX System Software Version 4.44A

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

¿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
    2015-08-05
  • Fecha de publicación del evento
    2015-08-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150805.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: bd max system software version 4.44a medical device manufacturer, bd, has issued a medical device safety alert concerning its bd max system software version 4.44a [serial number: ct0583]. the manufacturer has determined that bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. affected users utilizing only ivd assays are not affected. this anomaly may cause the osr customer system to incorrectly switch the columns of the truth table on the user’s display. if the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. the manufacturer is currently developing and validating an update to the software to correct this issue. the new software will be available by the end of august 2015. until the software can be updated on the affected instrument, users are reminded to follow osr workflow instructions to ensure that the above-described situation does not occur. no action is required for ivd assay users. according to the local supplier, 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 05 august 2015.

Device

BD MAX System Software Version 4.44A
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD MAX System Software Version 4.44A
  • Manufacturer
    BD

Manufacturer

BD