Events

Alerta De Seguridad para Dermatological alarm systems Skinmaster: (1) Beauty Pro 5, (2) Skin rejuvenation MD7

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Sybaritic Inc.

¿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
    312
  • Fecha
    2001-10-12
  • 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 above laser systems did not meet the requirements 21cfr 1040.11 (a) (2) in this case, the units were placed on the market without the safety label and consumer information required to meet the laser product performance standard, 21 cfr 1040.10 and 1040.11. the manufacturer initiated the correction by sending the labels and revised instructions to the users and reprinting the sales leaflets.
  • Acción
    Check receipt of security labels and instruction to the reviewed user submitted by Sybaritic. Identify and isolate all affected products in your inventory. Review the instruction to the updated user and affix the safety labels to the products in accordance with Sybaritic guidelines. For more information, contact your local representative or directly with Sybaritic at 1 (952) 888-8282 in the United States.

Device

Dermatological alarm systems Skinmaster: (1) Beauty Pro 5, (2) Skin rejuvenation MD7

Manufacturer

Sybaritic Inc
  • Source
    ANVSANVISA