Alerta De Seguridad para Styker’s Berchtold F-generation LED lights

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 styker’s berchtold f-generation led lights medical device manufacturer, medtronic, has issued a field safety notice (fsn) concerning certain styker’s berchtold f-generation led lights with affected model numbers of f528 (with a serial number smaller than 831800001526) and f628 (with a serial number smaller than 831710002819). there is the potential for electromagnetic interference (emi) between medtronic’s stealthstation axiem or fusion em technology and the abovementioned models of styker’s berchtold f-generation led lights. when the lights are positioned according to berchtold’s instructions for use – at a distance at least one meter from the patient – there is no interference. when the lights are positioned closer to the patient, the resulting emi causes the stealthstation axiem or fusion em system to cease tracking and display “red status”, which prevents navigation until the emi is removed. the testing confirmed that the stealthstation axiem/fusion system meets specification. if users have the devices with one of the affected serial number ranges above, they should consider limiting use of the axiem or fusion em system to rooms that do not have these lights installed. if no alternative room is available, customers are reminded to ensure use of the lights according to the berchtold instruction for use, maintaining a light head position at least one meter from the surgical site. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Styker’s Berchtold F-generation LED lights
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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