Events

Retiro De Equipo (Recall) de Leckey 4Point Pelvic Harness Belts

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 Patterson Medical Holdings, 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
    52114
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2040-2009
  • Fecha de inicio del evento
    2009-04-17
  • Fecha de publicación del evento
    2009-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82118
  • 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
    Mechanical chair - Product Code INN
  • Causa
    The plastic buckles on the hip belts of the 4-point pelvic harness may break.
  • Acción
    Sammons Preston, the U.S. agent for James Leckey Design Ltd., issued recall letters dated 4/17/09 to all of their customers who purchased the Leckey 4-Point Pelvic Harness, used in the Leckey Contoured Advance Seat, Leckey Early Sitting System and the Leckey Squiggles Saddle Seat, informing them that the manufacturer, James Leckey Design Ltd., is recalling the harness because the pelvic belt buckle may not lock securely and/or break. A copy of the Urgent Field Safety Notice dated 1/28/09 issued by Leckey in the United Kingdom was included with the Sammons letter. The customers were advised to be vigilant and check the hip belts daily to ensure that the user is secure in their seating system until the replacement hip belt is received. The accounts were requested to contact Carla Dreher at 1-800-288-3693, ext. 8724 for instructions on how to receive a replacement hip belt.

Device

Leckey 4Point Pelvic Harness Belts
  • Modelo / Serial
    All belts supplied on the affected seating systems between September 2007 and December 2008
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: || a) Leckey Contour Advance Seat, Size 1, catalog 081117209; || b) Leckey Contour Advance Seat, Size 2, catalog 081117217; || c) Leckey Squiggles Saddle Seat, catalog 081326941; || d) Leckey Early Sitting System, catalog 081395193
  • Manufacturer
    Patterson Medical Holdings, Inc.

Manufacturer

Patterson Medical Holdings, Inc.
  • Dirección del fabricante
    Patterson Medical Holdings, Inc., 1000 Remington Blvd Ste 210, Bolingbrook IL 60440-5116
  • Source
    USFDA