Events

Retiro De Equipo (Recall) de Device Recall BHM Medical Scales

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
    46210
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1136-2008
  • Fecha de inicio del evento
    2007-12-19
  • Fecha de publicación del evento
    2008-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66996
  • 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
    Medical Scales - Product Code FRW
  • Causa
    Unintended hanger bar detachment: the locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.
  • Acción
    Arjo sent Urgent Device Field Correction Notification letters dated 12/19/07 to the end user accounts who received the affected scales, advising them of the potential for the hanger bar assembly to detach. The accounts were given the option immediately stopping use of the lifts with the affected scales or removing the scales from the lift so the lift can continue to be used. Instructions for removal of the scales were provided with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating whether they will complete the correction upon receipt of the correction parts or if they require the assistance of an Arjo Service Technician.

Device

Device Recall BHM Medical Scales
  • Modelo / Serial
    Part 700.00525, Serial Numbers: ERSC-3064, ERSC-3065, ERSC-3066, ERSC-3068, ERSC-5858, ERSC-5859, ERSC-5860, ERSC-5861, ERSC-5864, ERSC-5866, ERSC-6765, ERSC-6767, ERSC-6768, ERSC-7729, ERSC-7742, ERSC-7769, ERSC-7776, ERSC-7779, ERSC-7780, ERSC-7781, ERSC-7784, ERSC-7787, ERSC-7789, ERSC-7790, ERSC-7791, and ERSC-8038,
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin.
  • Descripción del producto
    BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by BHM Medical Inc., Magog, QC, Canada; || These scales were sold for installation on the Model V10 and Model Maxisky fixed ceiling lifts manufactured by BHM Medical.
  • Manufacturer
    Arjo, Inc.

Manufacturer

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