Events

Alerta De Seguridad para Precision 500D, Legacy, RFX, and SFX X-ray imaging systems

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
    2013-10-02
  • Fecha de publicación del evento
    2013-10-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002a.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 precision 500d, legacy, rfx, and sfx x-ray imaging systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning precision 500d, legacy, rfx, and sfx x-ray imaging systems, manufactured by ge healthcare. the affected part numbers are 2258627, 2305472, 2305495, 2404103, 2403791, 2403791-3, 2403791-32, 2403791-40, 46-262751g2, 46-262751g4, 46-262751g5, 46-262751g6, 46-262751g7, and 46-262751g8. there is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. this issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the on position, and causing the system to strike the patient. no injuries have been reported to date related to this issue. the manufacturer advises users to inspect power assist handle for either of the two conditions listed below, and immediately contact local ge healthcare service representative if any issue is found. if users observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. if plastic grip is secure, but users observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always on), users may continue to use the device with care. use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop off. furthermore, ge healthcare will correct all affected systems. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: GE Healthcare Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare