Events

Retiro De Equipo (Recall) de EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd.

¿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
    RC-2013-RN-00320-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-04-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00320-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has determined that under certain circumstances the evotech endoscope cleaner and reprocessor system may not properly calculate the expiration date of the cidezyme xtra multi enzymatic detergent from the information entered by the user. in these circumstances, the expiration date displayed on the evotech ecr screen is one month after the labelled expiration date.
  • Acción
    Johnson & Johnson is providing instructions on how to identify if there is any discrepancy between the calculated expiration date and the labelled expiration date. Users are advised to adhere to the labelled expiration date.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
  • Modelo / Serial
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)Product code: 50004All lot/serial numbers affected.ARTG number: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd