Events

Retiro De Equipo (Recall) de Device Recall BHM Medical Infrared (IR) Hand Control System

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
    46800
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1233-2008
  • Fecha de inicio del evento
    2008-02-20
  • Fecha de publicación del evento
    2008-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68292
  • 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
    wireless control for patient lift - Product Code FNG
  • Causa
    The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.
  • Acción
    Arjo sent Urgent Device Field Correction Notification letters dated 2/15/08 on the BHM Medical letterhead to the end user accounts who received the affected IR remotes, advising them of the potential for the remote to become difficult to operate or to create uncontrolled movement of the ceiling lift. The accounts were instructed to remove the IR remote from service until the field correction is issued by BHM Medical. Instructions for removal of the IR equipment were provided in the Safety Advisory Notice included 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 the number of units requiring correction.

Device

Device Recall BHM Medical Infrared (IR) Hand Control System
  • Modelo / Serial
    There are no serial numbers on the BHM Medical Infrared (IR) Hand Control System, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board. The hand controls were installed on the following ceiling lifts: i) Maxi Sky 600, part LD10111, serial numbers LD-2605-15164, LD30733967, LD30733968, LD480627315, LD-5105-21404;  ii) V4, part 9100021, serial numbers V4-1107-29534, V4-1307-29837, V4-3307-33778, V4-1507-30147, V4-1905-14715, V4-4205-18404, V4-3606-26259, LD-1706-24108, V4-0206-22026, V4-3405-16157, V4-4606-27188, V4-4803-04671, V4-1307-29838, V4-1806-24149, V4-3307-33779, V4-4207-36144; part 9100021.13, serial numbers V4-0805-09557, V4-1006-23261; part 9100023, serial number V4-1406-23773; and part 9101021, serial number V4-0105-08044.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board
  • Manufacturer
    Arjo, Inc.

Manufacturer

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