Events

Retiro De Equipo (Recall) de BHS 301 SCULPTOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BODY HEALTH S.A..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    23958
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-07-01
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A notification was sent to the distributor informing them that the medical devices that were sold to them by body health s.A. were not licensed in accordance with the medical devices regulations.

Device

BHS 301 SCULPTOR
  • Modelo / Serial
    Model Catalog: BHS 301 SCULPTOR (Lot serial: 181108-0179); Model Catalog: BHS 102 (Lot serial: 120508-0113); Model Catalog: BHS 102 (Lot serial: 120508-0112); Model Catalog: BHS 102 (Lot serial: 080408-0094); Model Catalog: BHS 102 (Lot serial: 080408-0082); Model Catalog: BHS 302 (Lot serial: 050208-0087); Model Catalog: BHS 140 (Lot serial: 070607-0021); Model Catalog: BHS 202 (Lot serial: 090408-0090); Model Catalog: BHS 202 (Lot serial: 160708-0134); Model Catalog: BHS 135 (Lot serial: 140108-0238); Model Catalog: BHS 301 (Lot serial: 131108-0474); Model Catalog: BHS 301 (Lot serial: 131108-0472); Model Catalog: BHS 301 (Lot serial: 131108-0471); Model Catalog: BHS 130 (Lot serial: 201207-0137); Model Catalog: BHS 102 (Lot serial: 120508-0106); Model Catalog: BHS 102 (Lot serial: 120508-0116); Model Catalog: BHS 102 (Lot serial: 120508-0107); Model Catalog: BHS 102 (Lot serial: 120508-0115); Model Catalog: BHS 102 (Lot serial: 120508-0114)
  • Descripción del producto
    BHS 301 SCULPTOR
  • Manufacturer
    BODY HEALTH S.A.

Manufacturer

BODY HEALTH S.A.
  • Dirección del fabricante
    BUENOS AIRES
  • Empresa matriz del fabricante (2017)
    Body Health S.A.
  • Source
    HC