Events

Retiro De Equipo (Recall) de Entroy Pool Lift

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Arjo, Inc. dba ArjoHuntleigh.

¿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
    59588
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3070-2011
  • Fecha de inicio del evento
    2011-08-04
  • Fecha de publicación del evento
    2011-08-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103152
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lift, patient, non ac-powered - Product Code FSA
  • Causa
    The entroy pool lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver.
  • Acción
    ArjoHuntleigh sent an Urgent Field Correction Notice I.D. 110701AHE to the affected end user via UPS 2nd Day on August 4, 2011. The notice informed the account of the potential for lift boom to rapidly lower un-commanded to the bottom of its stroke. The account was requested to immediately cease use of the affected lift, and disconnect the power to the lift to prevent further use until corrected. The account was requested to complete and sign the Customer Response Form, and return it to ArjoHuntleigh to schedule a service call to correct the lift. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 54485.

Device

Entroy Pool Lift
  • Modelo / Serial
    Model GAB1000-01-US, serial number SEE0326028  Rest of the world: Models GAB1000-01-xx, GAB1000-11-xx and GAC100x, all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including CT
  • Descripción del producto
    Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100x || Entroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis.
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

Arjo, Inc. dba ArjoHuntleigh
  • Dirección del fabricante
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA