Events

Rappel de Leckey 4Point Pelvic Harness Belts

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Patterson Medical Holdings, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    52114
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2040-2009
  • Date de mise en oeuvre de l'événement
    2009-04-17
  • Date de publication de l'événement
    2009-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82118
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Mechanical chair - Product Code INN
  • Cause
    The plastic buckles on the hip belts of the 4-point pelvic harness may break.
  • Action
    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
  • Modèle / numéro de série
    All belts supplied on the affected seating systems between September 2007 and December 2008
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    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.
  • Adresse du fabricant
    Patterson Medical Holdings, Inc., 1000 Remington Blvd Ste 210, Bolingbrook IL 60440-5116
  • Source
    USFDA