Events

Rappel de Device Recall Eleganza 3 Hospital Bed

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 Linet Americas 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
    58785
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2411-2011
  • Date de mise en oeuvre de l'événement
    2011-05-02
  • Date de publication de l'événement
    2011-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100295
  • 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, hydraulic, adjustable hospital - Product Code FNK
  • Cause
    Linet has been made aware that there has been breakage of the mobi-lift handle on a few beds which may cause failure during patient assist use.
  • Action
    The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up "service advisory information" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Linet Americas will be receiving a supply of new Mobi-lift design and will begin the process of executing service calls to replace the Morbi-lift handles with the new design. If you have any questions, contact the Director of Quality and Service Operations at 704-248-5650 or 980-406-6446.

Device

Device Recall Eleganza 3 Hospital Bed
  • Modèle / numéro de série
    Models: Eleganza 3 (1GZ17045 with Scale) or (1GZ07045 without Scale), Accesory: Mobi-lift handle (P/N D310105B) (Located towards the foot side of bed on both sides), Serial Numbers: 20100043034 to 20100043045
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.
  • Description du dispositif
    Eleganza 3 Hospital Bed || Intended use: AC Powered adjustable Hospital Bed
  • Manufacturer
    Linet Americas Inc

Manufacturer

Linet Americas Inc
  • Adresse du fabricant
    Linet Americas Inc, 10430 Harris Oak Blvd, Ste A, Charlotte NC 28269-7511
  • Société-mère du fabricant (2017)
    Linet Americas Inc.
  • Source
    USFDA