Events

Alerta De Seguridad para Clear Tape Electromagnetic Electrode: (1) Model 1680 Radiotranslucent, (2) Model 1690 UltraTrace Long-term adult multi-use monitoring. Catalog No. (1) 1680-001, 1680-005, 1680-030; (2) 1690-001, 1690-003, 1690-005, 1690-010, 1690-030; Lots Nos .: (1) 9909181, 9909231, 9909232, 9909271, 9909272, 9909291, 9909292, 9910011, 9910012, 9910052, 9910061, 9910071, 9910081, 9910082, 9910131; (2) 9909131, 9909141, 9909142, 9909152, 9909152, 9909152, 9909202, 9909202, 9909111, 9909241, 9909241, 9909251, 9909291, 9909291, 9909301, 9910041, 9910051, 9910052, 9910071, 9910081, 9910121, 9910122, 9910132, 9910141, 9910142 , 9910151, 9910192, 9910202, 9910221, 9910261, 9910262, 9910271, 9910291, 9911011, 9911031, 9911041

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por CONMED Corp.

¿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
    236
  • Fecha
    2000-12-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Some electrocardiographic electrodes (ecgs) of the aforementioned lots may show separation of the sensitive element from the electrode body, causing electrode malfunction. the manufacturer initiated a removal by letter dated september 20, 2000 and faxed on september 21 and 22, 2000.
  • Acción
    Make sure you have received the letter, return form, and business letter return envelope sent on September 20, 2000, and faxes dated September 21 or 22, 2000 from Conmed. Identify and isolate any defective product from your inventory. Complete and return the form in the envelope provided. Immediately return defective product by UPS or equivalent delivery service to Conmed, Attention: Returned Goods-ECG Recall, at the above address. If you have distributed any problem products, please contact your customers, and ask them to return the product to the address listed. Conmed will replace all returned electrodes and will reimburse shipping costs. For more information, contact your local representative or directly with Sandra Flack, Conmed, at 1 (315) 797-8375 in the USA.

Device

Clear Tape Electromagnetic Electrode: (1) Model 1680 Radiotranslucent, (2) Model 1690 UltraTrace ...

Manufacturer

CONMED Corp
  • Source
    ANVSANVISA