Events

Alerta De Seguridad para LOGIQ S7 and S8

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

¿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
    2013-04-18
  • Fecha de publicación del evento
    2013-04-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130418a.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: ge healthcare logiq s7 and s8 the united states food and drug administration (fda) has issued a medical device safety alert concerning logiq s8 (with software revisions r1.1.1 and r1.5.1) and s7 (with software revisions r1.0.1, r1.0.2 and r1.0.3) diagnostic ultrasound system with the s4-10-d ultrasound probe manufactured by ge healthcare, llc. according to the safety alert, ge healthcare has become aware of a potential safety issue due to the s4-10-d ultrasound probe used in conjunction with the logiq s8 and logiq s7 ultrasound systems. it was discovered that this issue also leads to a specification issue of the acoustic output of this probe. there is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe. for details, please visit the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm? action=detail&id=64725&w=04172013&lang=eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 april 2013.

Device

LOGIQ S7 and S8
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare LOGIQ S7 and S8
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare