Retiro De Equipo (Recall) de MedilifterIII Plus and Summit Total 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Patient Lift - Product Code FSA
  • Causa
    Scale could break and fall potentially causing injuries to someone who is on it. there is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. should a patient be in the lift at the time, the patient could fall and sustain injuries.
  • Acción
    Arjo sent Urgent Device Recall Customer Notification letters dated 4/1/08 on the BHM Medical letterhead to the end user accounts who received the affected patient lifts with mast scales, advising them of the potential of fracture at the load cell assembly which might cause the scale to fall. Should a patient be in the lift at the time, the patient could fall, potentially sustaining injuries. The accounts were instructed to immediately stop using the patient lifts. A BHM representative will contact the accounts within 5 days to arrange for the correction of the lifts. The accounts will be given the option of returning the lifts for repair (with shipping costs covered by BHM), or purchasing a replacement lift at a significantly reduced price. Any questions or concerns were directed to the BHM Service Department at 1-819-868-0441 or


  • Modelo / Serial
    Medi-Lifter III Plus, serial numbers 76001/1013, 76003/1015, 76004/1014, 76005/1017, 76027/1019, 76028/1012, 76058/1024, 76128/1034, 76129/1025, 76132/1031, 76133/1039, 76162/1033, 76164/1035, 76221/1069, 76247/1065, 76251/1070, 77091/1079, 77092/1088, 77093/1083, 77126/1084, 77127/1085, 77295/1091, 77342/1096, 77343/1093, 77406/1099, 77407/1098, 77408/1092, 78035/1134, 78036/1132, 78037/1133, 78038/1128, 78039/1103, 78040/1130, 78041/1104;   Summit, serial numbers 4800157/1020, 4800166/1077, 4800173/1086
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.
  • Descripción del producto
    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); || Mast scale is Intended to be used for weighing patients while in the lifter. || Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5
  • Manufacturer


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