Events

Alerta De Seguridad para Mobile Model X-ray Systems BV 300. Parts Nos .: 9896 000 06801, 9806 000 06802; In Series: DBXXX, DDXXX, DEXXX (where X in any position corresponds to numbers 0 to 9), DG0001 to DG0129, DH0001 to DH0033, DJ0001 to DJ0152, DK0001 to DK0076

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems North America.

¿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
    691
  • Fecha
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The c-tilt support, in the aforementioned x-ray systems, can bend or break, allowing the c-arm to fall out of the support and reach a patient. the manufacturer notified by letter dated 27 september 2002.
  • Acción
    Make sure you received the letter from Philips on 27 September 2002. Identify and isolate any affected product in your inventory. Contact your local Philips representative for additional information, to schedule a technical visit in your area, and to arrange the units in your inventory. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Mobile Model X-ray Systems BV 300. Parts Nos .: 9896 000 06801, 9806 000 06802; In Series: DBXXX,...

Manufacturer

Philips Medical Systems North America
  • Source
    ANVSANVISA