Events

Rappel de Maxi Move Scoop Stretcher

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 ArjoHuntleigh.

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
    52824
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2230-2009
  • Date de mise en oeuvre de l'événement
    2009-08-18
  • Date de publication de l'événement
    2009-09-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84080
  • 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
    Non-AC-powered Patient Lift - Product Code FSA
  • Cause
    A scoop stretcher is made up of two frames that are held together with two locking devices, one on each end. each locking device contains a safety latch. the safety latch could unintentionally release when the side frames are pulled for positioning.
  • Action
    ArjoHuntleigh sent their customers a cover letter and the Field Safety Notification, informing them of the potential problem with the safety latches on the stretcher and a pending visit from an ArjoHuntleigh Service Technician to correct the problem. These letters were sent via UPS 2nd day delivery on 8/18/09. The customers were requested to test their stretchers upon receipt of the letter following the instructions for checking the safety latches on the stretcher: * Place the stretcher on its side on a non-scratch surface. * Try to pull the two sides apart with the safety latch engaged. * Test both the head and foot ends of the stretcher. * If the stretcher pulls apart, remove it from use immediately. It is important to note that all affected stretchers will be upgraded, whether they fail the test or not.

Device

Maxi Move Scoop Stretcher
  • Modèle / numéro de série
    all six digit serial numbers beginning with 6xxxxx and all serial numbers 08xxxxxxxx up to 0812001186.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.
  • Manufacturer
    ArjoHuntleigh

Manufacturer

ArjoHuntleigh
  • Adresse du fabricant
    ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA