Events

Rappel de Entroy Pool Lift

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 Arjo, Inc. dba 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
    59588
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3070-2011
  • Date de mise en oeuvre de l'événement
    2011-08-04
  • Date de publication de l'événement
    2011-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103152
  • 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
    Lift, patient, non ac-powered - Product Code FSA
  • Cause
    The entroy pool lift boom may rapidly lower un-commanded to the bottom of its stroke, with a potential for injury to the resident or caregiver.
  • Action
    ArjoHuntleigh sent an Urgent Field Correction Notice I.D. 110701AHE to the affected end user via UPS 2nd Day on August 4, 2011. The notice informed the account of the potential for lift boom to rapidly lower un-commanded to the bottom of its stroke. The account was requested to immediately cease use of the affected lift, and disconnect the power to the lift to prevent further use until corrected. The account was requested to complete and sign the Customer Response Form, and return it to ArjoHuntleigh to schedule a service call to correct the lift. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 54485.

Device

Entroy Pool Lift
  • Modèle / numéro de série
    Model GAB1000-01-US, serial number SEE0326028  Rest of the world: Models GAB1000-01-xx, GAB1000-11-xx and GAC100x, all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CT
  • Description du dispositif
    Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100x || Entroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis.
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

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