Events

Retiro De Equipo (Recall) de Device Recall Faaborg Person Lift, PL Series

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 Moving Solutions, 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
    28199
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0551-04
  • Fecha de inicio del evento
    2004-01-21
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-10-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31367
  • 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
    Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
  • Acción
    Letters were sent to all Faaborg lift customers on 11/29/01 and 01/24/04 advising the users that all bolts in connection with the hanger bar must be inspected, greased and tightened, and all defective or worn down bolts and washers must be changed. The 1/24/04 letters included an upgraded maintenance schedule and an Important Service/Safety Reminder, as well as a supply of hanger bar bolt washers. Any questions were directed to Moving Solutions' Service Department at 800-228-7980. Follow-up letters were sent to the accounts on 3/11/04, referencing the 1/21/04 letter and instructing the accounts not to use the lifts until the bolts have been inspected and retrofitted with the washers. Copies of the revised maintenance schedule and operating instructions were included.

Device

Device Recall Faaborg Person Lift, PL Series
  • Modelo / Serial
    all PL series models, all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide to nursing homes, residential schools and home patients, and internationally to Canada.
  • Descripción del producto
    Faaborg patient lift/hoist, battery operated lifts. The PL series lifts have electric parallel base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.
  • Manufacturer
    Moving Solutions, Inc.

Manufacturer

Moving Solutions, Inc.
  • Dirección del fabricante
    Moving Solutions, Inc., 2550 Wisconsin Ave, Downers Grove IL 60515
  • Source
    USFDA