Events

Alerta De Seguridad para X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III Model Affected: Brivo OEC 715, Brivo OEC 785, Brivo OEC 865 Affected serial numbers: • GE Brivo OEC715: Series numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051; • GE Brivo OEC785: Series numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152; • GE Brivo OEC865: Series numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Hualun Medical Systems CO., LTD / GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda..

¿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
    2142
  • Fecha
    2016-10-04
  • 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
    Before starting the procedure, the operator must check that the C-arc moves up and down normally, and that the emergency stop button is working correctly. If the C-arc moves up or down without a command, during a procedure, the user must press the emergency stop button to prevent the C-arc from colliding with medical instruments. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Causa
    The plate that controls the vertical movement of the c-arc can fail and result in c-arc movement up or down, without command. there were no injuries reported as a result of this problem. however, this problem can cause soft tissue damage if the c-bow moves down during a surgical procedure and collides with the medical instruments.
  • Acción
    Field Action IMF Code 15132 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.

Device

X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Hualun Medi...