Events

Retiro De Equipo (Recall) de STERRAD 100NX (Gas Plasma Steriliser)

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-01242-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-11-22
  • 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-01242-1
  • 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, asp has determined that welds could loosen on the frame of sterrad 100nx sterilizers manufactured between october 2012 and june 2013. these welds are used to secure support rails to the top tray assembly for added rigidity. the failure of the broken weld could potentially cause the chassis to deflect concaving downward. this failure does not impact the sterrad 100nx sterilizer components performance.
  • Acción
    A JJM Field Service Engineer will install rivets and brackets to ensure the support rail brackets are firmly attached to the chassis to prevent possible separation.

Device

STERRAD 100NX (Gas Plasma Steriliser)
  • Modelo / Serial
    STERRAD 100NX (Gas Plasma Steriliser)Product Number: 10104-002Affected Serial Numbers: 1042130065, 1042130028, 1042130024, 1042130067, 1042130002, 1042130063, 1042130064ARTG Number: 123603
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd