Events

Alerta De Seguridad para Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic Navigation.

¿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
  • Fecha
    2013-07-19
  • Fecha de publicación del evento
    2013-07-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130719.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic navigation stealthstation s7 and i7 systems and planning station containing framelink software version 5.4 medical device manufacturer, medtronic navigation, inc. issued a medical device safety alert concerning navigation stealthstation s7 and i7 systems and planning station containing framelink software version 5.4. the following part numbers are affected: 9734047 (framelink s7 applications kit) 9734066 (framelink s7 planning station kit) 9733986 (framelink application software) medtronic has identified that the use of high resolution exams (greater than 256 x 256) under certain conditions may cause the look-ahead view labels to show user selected depths (displayed), but the corresponding images are shown at a depth twice the selected distance. under these conditions, visualization of the planned trajectory could show the image at the incorrect depth. medtronic has received three customer reports related to this issue. none of the reports cited any patient injuries or adverse events. according to the manufacturer, the framelink software version 5.4 has been revised to correct the software anomalies mentioned above. until the software upgrade has been installed, users are advised not to use high resolution examinations (greater than 256 x 256). if users are not sure of the exam resolution being used, they should contact the local supplier for assistance. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 july 2013.

Device

Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Ve...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4
  • Manufacturer
    Medtronic Navigation

Manufacturer

Medtronic Navigation
  • 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
    DH