Events

Alerta De Seguridad para Two Products Affected :. 1 - DIAGNOSTIC SYSTEM BY IMAGEMO-arm® 1000 / Models numbers BI-700-00027 and BI-700-00028 :. • Commercial name; DIAGNOSTIC SYSTEM BY IMAGE. • Technical Name; Surgical arch. • Registration classification: EQUIPMENT. • ANVISA Registry Number: 10339190302. • Classification of Risk: Class III (High Risk). . 2 - MOBILE SYSTEM OF IMAGIOLOGY OR®Arm 2 / Model number BI-700-02000. • Commercial Name: O'Arm Mobile Imaging System 2. • Technical Name: Mobile X-ray Apparatus. • Classification in register: EQUIPMENT. • ANVISA Registry Number: 10339190638. • Classification of Risk: Class III (High Risk)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA; O fabricante Legal e o Físico é a Medtronic Navigation 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
    2052
  • Fecha
    2016-07-19
  • 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
    According to the company, the purpose of this action is to provide an update of Software and Instructions for Use related to the O-ARM ® system, as well as to carry out a visit to make appropriate measurements of the air kerma rate and tests of the accuracy of the display of the X-ray technical factor to meet compliance. We will also perform a visual and electrical inspection of the batteries for possible damage (this visual inspection will be exclusive to O-ARM® 1000 Models numbers BI-700-00027 and BI-700-00028). 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
  • Causa
    This field action is intended to update o-arm® software and instructions for use to maintain compliance with applicable performance standards. these updates refer to two models of different o-arm® systems, as described in the specifications of each fa726 customer letter referring to the following models: imagemo-arm® 1000 diagnostic system / model numbers bi-700-00027 and bi- 700-00028; - mobile imaging system o®arm 2 / model number bi-700-02000.
  • Acción
    Field Action Code FA726 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA for Field Correction to update software and update instructions for use.

Device

Two Products Affected :. 1 - DIAGNOSTIC SYSTEM BY IMAGEMO-arm® 1000 / Models numbers BI-700-00027...

Manufacturer

MEDTRONIC COMERCIAL LTDA; O fabricante Legal e o Físico é a Medtronic Navigation INC
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA