Events

Retiro De Equipo (Recall) de CMAX SURGICAL TABLE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STERIS CANADA INCORPORATED.

¿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
    82310
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-09-07
  • 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
    Steris corporation has learned that cmax surigical tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. this could result in the table moving into an unexpected tilt position when the "level" button is depressed on the hand control keypad. the likelihood of this event occurring is remote as the cmax surgical table opertor manual states to always connect the ac power cord to an appropriate ac receptacle as often and as long as possible with the main power switch set to on.

Device

CMAX SURGICAL TABLE
  • Modelo / Serial
    Model Catalog: CMAX 110 (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 110 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832050 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832051 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832JEJ (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 220 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832050 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832050 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: CMAX 110 (Lot serial: S/N: 0428208115 TO 0417309157)
  • Descripción del producto
    CMAX SURGICAL TABLE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    HC