Events

Retiro De Equipo (Recall) de Steris 4085 series Surgical Table

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Steris Corporation.

¿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
    17162
  • Fecha de inicio del evento
    2014-08-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Steris has determined there is a potential that if the surgical table feet become unlocked from the floor during a procedure, the hand control may incorrectly indicate that the table feet are locked and still contacting the floor. the user may not realize that the table is unlocked and is able to continue articulating the table using the hand control. should this occur, the table can be relocked by pressing the floor lock button on the table hand control.
  • Acción
    Product to be modified

Device

Steris 4085 series Surgical Table
  • Modelo / Serial
    Model: Models: 4085, 4085SS and 4085 Feather Weight Leg Sction, Affected:
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    NZMMDSA