Events

Alerta De Seguridad para SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips 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
    2015-06-24
  • Fecha de publicación del evento
    2015-06-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150624.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: sense body coil 1.5t used with acs nt, intera 1.5t and achieva 1.5t mr system medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its sense body coil 1.5t used with acs nt, intera 1.5t and achieva 1.5t mr system. according to the manufacturer, if users do not follow the instructions for use (ifu) concerning the positioning of the sense body coil 1.5t and its cables in relation to the patient and mr bore, unintended resonances could be created via the patient or elevated coil cable temperature due to rf coupling to the quadrate body coil during an examination. this may result in patient burns. the manufacturer advised users to follow the ifu to position the affected product. according to the local supplier, only the model “achieva 1.5t (system code: 781296; serial numbers: 33532, 33162, 32691, 32680, 32787) is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2015.

Device

SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH