Events

Retiro De Equipo (Recall) de Minstrel Patient 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..

¿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
    28958
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0970-04
  • Fecha de inicio del evento
    2004-04-30
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32871
  • 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 hanger bar may detach from the jib yoke, and the m8 bolt in the foot pedal assembly may come loose, resulting in the patient lift becoming unstable.
  • Acción
    Field Correction Notification letters dated 4/30/04 were sent by certified mail to the end users, informing them of the possibility of the hanger bar assembly to detach from the jib due wear of the pivot assembly within the yoke. They were also advised that the bolt in the foot pedal assembly could come loose, rendering the lift unstable. The users were requested to inspect their lifts or take them out of service pending service by an Arjo service engineer. The users were requested to complete customer response form indicating the model numbers and serial numbers of the lifts at the facility, both in use and out of service, and either mail or fax the form back to Arjo. Within two weeks an Arjo service engineer will contact each facility to schedule an appointment to service the lifts at Arjo's expense. Any questions were directed to Don Smith, Technical Service Director, at 1-800-323-1245, ext. 6167.

Device

Minstrel Patient Lift
  • Modelo / Serial
    model numbers HMB001-US and HMB002-US, all units with and without scales up to and including serial number MPLAT0307W855
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, Georgia, Maryland, West Virginia, Texas, Tennessee, South Carolina, Kansas, Nebraska, Hawaii, Massachusetts, Ohio, Minnesota, Pennsylvania, Connecticut and Colorado.
  • Descripción del producto
    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Dirección del fabricante
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA