Events

Alerta De Seguridad para Scooters, Indoor / Outdoor, Motorized, 3 Wheel, Revo: (1) Model SC60RBLU blue, (2) Model SC60RRED red, (3) Model SC60RYEL yellow

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Pride Mobility Products 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
    316
  • Fecha
    2001-10-26
  • 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
    The steering system on the above scooters can engage while the handbrake is inactive. the manufacturer sent a safety alert letter dated may 18, 2001 that provides assistance to the reseller and product warranty. the company did not provide any information to ecri.
  • Acción
    Check the receipt of the security alert letter dated May 18, 2001 from Pride Mobility Products. Identify and isolate all affected products in your inventory. For more information, contact your local representative or directly with Pride Mobility Products at 1 (888) 570-1113 in the United States.

Device

Scooters, Indoor / Outdoor, Motorized, 3 Wheel, Revo: (1) Model SC60RBLU blue, (2) Model SC60RRED...

Manufacturer

Pride Mobility Products Corp
  • Source
    ANVSANVISA