Alerta De Seguridad para Trade name: Surgical Focus Rolite Volista Standop. Technical Name: Surgical Focus. ANVISA registration number: 80259110090. Risk class: I. Model affected: Rolite Volista 400; Rolite Volista 600. Series numbers affected: All VOLISTA StandOP / TRIOP domes, manufactured until 06/2017 and equipped with the ARD568801560 keypad.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Maquet do Brasil Equipamentos Medicos Ltda.; MAQUET SAS..

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    This is to replace possibly defective keyboards with new keyboards. Please make sure that all caretakers and users of the VOLISTA StandOP and TRIOP domes referenced in the consignee list are aware of this Field Notification and that all devices in your unit are available to be replaced by an authorized Getinge service technician. This field notification for the Standop Volista and TRIOP from Getinge needs to be distributed to individuals who need to be aware within their organization - or to any organization to which the potentially affected devices have been transferred. Be aware of this notification and the action outcome for the period of use of the device to ensure the effectiveness of such corrective action. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/16/2018 - Date of notification notice to Anvisa: 04/09/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Possible keyboard failure of the volista standop and triop surgical spotlights. this possible malfunction is caused by an internal frequency problem of a component on the keyboard in version 1 and by the touch sensitivity technology that was not sensitive enough in versions 2 and 3. the keyboards in question are no longer produced. this is to replace possibly defective keyboards with new keyboards.
  • Acción
    Field Action Code MAS / 2017/001 / IU triggered under the responsibility of Maquet do Brasil Equipamentos Medicos Ltda. Field correction.


  • Empresa matriz del fabricante (2017)
  • Source