Events

Alerta De Seguridad para SSCOR Electric Suction Pumps (1) Model 2500, (2) Model 10552, (3) Model 15002, (4) Model 40014, (5) Model 45000, (6) Model 64000, (7) Model 64000-220, 8) Model 90024, (9) Model 90032. Series Nos.: (1) 250 to 1027, (2) 2655 to 3152, (3) 628 to 3603, (4) 5802 to 6499, (5) 1142, (6) 4881 to 8381, (7) 1008 to 1128, (8), 1854 to 2290, (9), 2216 to 2388

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

¿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
    214
  • Fecha
    2000-12-01
  • 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
    There may be cracks in the plastic fuse holders where the fuse necessary to recharge the described suction pumps is located. these cracks may cause the fuse to fall from the stand or prevent the unit from recharging. the manufacturer commenced a mail removal on june 28, 2000.
  • Acción
    Make sure you have received the correspondence dated June 28, 2000 and the response card with the corrections on the SSCOR equipment. Identify and isolate any affected product from your inventory. Inspect the pump harnesses by removing the bolts connecting the top cover to the back panel to the metal units or by opening the fabric cover zipper or by lifting the velcro tab to the flexible units. If you find any cracks or problems in the fuse holder, contact Scott Eamer, SSCOR, at 1 (818) 504-4054 ​​in the United States for parts replacement or to schedule fabric repair for the suction pump. Fill in the Equipment Correction Response Card and return it to SSCOR by the postal delivery service to the address listed, accompanied by the damaged product. For more information, contact Scott Eamer, SSCOR, at 1 (818) 504-4054 ​​in the United States.

Device

SSCOR Electric Suction Pumps (1) Model 2500, (2) Model 10552, (3) Model 15002, (4) Model 40014, (...

Manufacturer

SSCOR Inc
  • Source
    ANVSANVISA