Events

Alerta De Seguridad para Trade Name: Tissue Processor Technical Name: Tissue Processor ANVISA Registration Number: 10337990010 Hazard Class: I Affected Model: Leica ASP6025 Serial numbers affected: 321, 381, 390, 410, 436, 495, 500, 553, 559 , 597, 608, 624, 626, 657, 699, 729, 731, 733, 760, 769, 898, 939, 979, 1089, 1109

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Leica do Brasil Importação e Comércio Ltda; 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
    2315
  • Fecha
    2017-06-14
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    As an immediate recommendation, the manufacturer guides the removal of the remote alarm label on the back of the equipment. 120V information should no longer be available on the instrument. Within a few days, the manufacturer will send the new, corrected labels to the Leica engineering area so that they can be glued to the equipment.
  • Causa
    The equipment in question has a remote alarm. the affected devices mentioned above are labeled incorrectly with respect to the voltage specified for the alarm connectors on the back of the equipment. the correct information is 30va.C, however, the current labels specify 125va.C as the maximum supported voltage. it was identified that if such a voltage is connected, to the 1/4 "stereo connector there would be a dangerous voltage accessible at the plug, which could lead to an electrical incident. in addition, the rear label picture of the equipment is incorrect in the use instruction, necessitating the need to update the user manual as well.
  • Acción
    Field Action Code NCMR-No .: 134881 triggered under the responsibility of the company Leica do Brasil Importação e Comércio Ltda. Company will make correction in the field.

Device

Trade Name: Tissue Processor Technical Name: Tissue Processor ANVISA Registration Number: 1033799...

Manufacturer

Leica do Brasil Importação e Comércio Ltda; Leica Biosystems Nussloch GmbH