Events

Alerta De Seguridad para Commercial Name: Lightspeed Computed Tomography System. ANVISA registration number: 80071260076. Risk class: III. Affected model (s); and Lot (s) / Serial number (s) affected :. 00000327271CN3 (São Paulo-SP). 00000346702CN4 (Goiânia-GO); 00000002103PT0 (Ribeirão Preto-SP). 00000003306EN8 (São Paulo-SP). 00000310682CN0 (Porto Alegre, RS); 00001002103YM8 (Santana-RS); 00000004411PT5 (Goiânia-GO). 00000004411PT5 (São Paulo-SP). 00000003310EN0 (São Paulo-SP). 00000383739CN0 (Pouso Alegre-MG). The following CT scanners are affected by this field action. - LightSpeed ​​Ultra (MDAS of 8 cuts), LightSpeed ​​Plus (MDAS of 4 cuts), LightSpeed ​​QX / i (MDAS of 4 cuts) and LightSpeed ​​16 (only MDAS) ... The following CT scanners are affected by this field action. - Discovery ST and Discovery LS.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE HANGWEI MEDICAL SYSTEMS CO, LTD. .

¿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
  • ID del evento
    1826
  • Fecha
    2016-02-19
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Users should ensure that those responsible for maintaining the equipment use the latest version of the Service Manual to maintain the safe and adequate performance of medical equipment. Users may continue to use Lightspeed CT, Discovery ST PET CT or Discovery LS PET CT systems. If maintenance of the system is performed by GE Healthcare, GE has confirmed that no further action is required on the power supply; however, users should update the Service Manual as instructed in the Urgent Security Notice Letter, attached to this form, in the "Product Fix" section. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and replacement parts.
  • Causa
    Ge has updated the service manuals for the products mentioned in this notice to correct an incorrect torque value. this field action is to inform customers about this update. the service manual update was performed due to the maintenance procedure, which describes replacing the power supply on the rotating side of the gantry, specifying an incorrect torque value on the mounting hardware. due to this error, the three fastening screws that attach to the power supply may have excess torque if the power supply has been replaced in the system.
  • Acción
    a) Risk Classification: CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. b) Classification of Field Action: Other. Specify: Send letter with instructions for updating the Service Manual. c) Field Action Code: IMF 25467 d) Recommendations to Users and Patients: Users should ensure that those responsible for maintaining the equipment use the latest version of the Service Manual to maintain the safe and adequate performance of medical equipment. Users may continue to use Lightspeed CT, Discovery ST PET CT or Discovery LS PET CT systems. If maintenance of the system is performed by GE Healthcare, GE has confirmed that no further action is required on the power supply; however, users should update the Service Manual as instructed in the Urgent Security Notice Letter, attached to this form, in the "Product Fix" section.

Device

Commercial Name: Lightspeed Computed Tomography System. ANVISA registration number: 80071260076. ...

Manufacturer

GE HANGWEI MEDICAL SYSTEMS CO, LTD.