Alerta De Seguridad para CENTRIFUGAL COMBAT (ANVISA Registry No. 80197039011), affected batches: 100804 and 110115 (series: from 6334 to 6391), affected batches: 100804 and 110115 (series: from 6334 to 6391) .

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CELM CIA EQUIPADORA DE LABORATORIOS MODERNOS.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    According to the company, the field action was initiated in view of a complaint from a customer, who noticed that the engine of the equipment was slack, produced unusual noise and stopped suddenly during use. After a root-cause analysis, it was detected that the motor support was broken and that it had small cracks, possibly due to inadequate design of the motor base. The company made improvements in the part and validated the new project, through tests of operation under extreme conditions of use. #### Update (10/26/2012): The company reported having terminated the corrective action on August 23, 2012, correcting 96 equipment (out of a total of 108 units).
  • Causa
    Possibility of breaking the motor base of the centrifuge.
  • Acción
    The company initiated the corrective action and informed UTVIG that it had already sent replacement parts to 80% of the affected products. If your Health Center has product (s) affected by this field action and has not yet been contacted by CELM Authorized Technical Assistance, you must notify the company to arrange for the correction of your health condition (s) equipment - see address, telephone and company email in the Manufacturer's Description field.