Events

Retiro De Equipo (Recall) de AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

¿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
    58887
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-05-08
  • 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
    When using a customized pet vcar percist protocol with more than 1 target lesion selected for response calculation the software may compute an incorrect response percentage and/or criteria whereby the number of lesions used to calculate response on the prior study is different than the number of lesions used to calculate response on the follow-up study. in which case the response criteria generated under this condition will compare the sum of the target findings from the prior to the sum of findings on the follow-up study resulting in an incorrect response percentage. this error could lead to an incorrect response criteria categorization [i.E. a patient that is responding to treatment (partial metabolic response - pmr) could be categorized as not responding (stable metabolic disease - smd) or progressive (progressive metabolic disease - pmd).] miscategorization of this type could lead to changes in the course of patient treatment.

Device

AW VOLUMESHARE 5 - VOLUME VIEWER OPTIONS
  • Modelo / Serial
    Model Catalog: 5422769-X (Lot serial: 00000LA713783D); Model Catalog: 5422769-X (Lot serial: 00000L3A330899); Model Catalog: 5422769-X (Lot serial: 00000L3A87FE86); Model Catalog: 5422769-X (Lot serial: 00000L3A86843C); Model Catalog: 5422769-X (Lot serial: 00000L3A3305A1); Model Catalog: 5422769-X (Lot serial: 00000LA703D3E9); Model Catalog: 5422769-X (Lot serial: 00000LA7142C7C); Model Catalog: 5422769-X (Lot serial: 00000LA712A01B)
  • Descripción del producto
    PET VCAR
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)