Events

Alerta De Seguridad para Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affected model (s); and Lot (s) / Serial number (s) affected: OPTIMA XR220AMX ... The Optima XR200amx and BRIVO XR285amx X-ray systems (ANVISA Registration 80071260246) are also affected.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil.

¿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
    1785
  • Fecha
    2015-01-05
  • 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
    Dropping the arm assembly can result in personal injury to a person. To date, there have been no incidents or injuries reported as a result of this security problem found internally. ### Field Action Update: UPDATED ON 10/23/2017, the company filed the field action completion report verifying the sending the security warning to the client with evidence of science and all actions completed.
  • Causa
    Problem related to the operation of the safety lock of the column that supports the horizontal arm. this safety latch mechanism acts as backup in the unlikely event of the primary safety cable breaking.
  • Acción
    CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. / / Field Action: Field Correction - Parts / Parts Correction. /// Field Action Code: IMF 10906./// The system may continue to be used. A GE Healthcare representative will contact the establishments that have equipment affected by this field action to arrange for correction.

Device

Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affe...

Manufacturer

GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil