Events

Rappel de Device Recall Rolko Trapeze handles

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 Hill-Rom, 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
    56033
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2094-2010
  • Date de mise en oeuvre de l'événement
    2010-06-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92462
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Cause
    The firm received a complaint regarding the plastic housing used to support the trapeze handle. the firm investigated and found that the manufacturer of the trapeze handle didn't correctly process the plastic component. therefore the plastic had the potential to break prematurely.
  • Action
    The firm, Hill-Rom, sent an "Urgent Field Safety Notice" letter dated June 11, 2010, to its customers. The letter describes the product, problem and action to be taken by the customers. Hill-Rom provided the quantity of handles needed to replace handles customers received during the affected period. The customers were instructed to immediately remove and replace all Trapeze Handles that were delivered during the affected period; to replace the Trapeze Handle Assemblies (with a manufacturing date from January 2007 to January 2009) used on their Patient Helper with the enclosed unit(s); complete and return the Customer Response Form as soon as possible, or by July 26, 2010; advise the firm immediately if they have relocated the beds and/or the accessories to another location, and forward the letter to any other facility personnel they deem appropriate. If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Device Recall Rolko Trapeze handles
  • Modèle / numéro de série
    Product has no code.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and Canada.
  • Description du dispositif
    Rolko Trapeze handles, part 148671, for use with Care Assist bed P1170 and Hill Rom 1000 bed P1160, Hill Rom Batesville, IN. || Intended Use: The CareAssist and Hill-Rom 1000 Beds are intended for low to moderate acuity patients in the medical/surgical area of the Hospital. The Rolko Trapeze handle is used by the patient to help reposition themselves while lying in the bed.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA