Events

Retiro De Equipo (Recall) de SPIRIT BED

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

¿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
    105723
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-09
  • 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
    The spirit plus and spirit select beds have actuators called the hi-lo actuators that allow for the bed to be raised and lowered. each bed has two actuators one that controls the headend of the bed's movement and one for the foot end. the actuators are mounted to the frame by use of a clevis pin design. the beds lower to a minimum height of 10.75 inches and a maximum height of 34 inches. it was identified that in some situations the actuator may break at the mount end.

Device

SPIRIT BED
  • Modelo / Serial
    Model Catalog: N3F02BCEF (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N2F00 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02BCEFMP196 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3FW2EM-06-06 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2F02BEMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2F02EM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3FY2YBEY (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F03BCEMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2F02E (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02CEP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02BCEMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N2FY2YEY (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N3F02CEFM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N3F02EFM (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N3F03BCEFMP1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: Z-N3F02 (Lot serial: >10 NUMBERS CON
  • Descripción del producto
    SPIRIT PLUS AND SPIRIT SELECT BED
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC