Events

Rappel de Maxilift

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
    52126
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1945-2009
  • Date de mise en oeuvre de l'événement
    2009-04-27
  • Date de publication de l'événement
    2009-08-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82161
  • 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
    The roll pin on certain configurations of the maxilift hanger bar could break due to a combination of severe corrosion and fatigue. breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
  • Action
    ArjoHuntleigh sent a Field Safety Notice DCHU-UK/0209/001FSN to all affected end users via UPS Ground on 4/27/09. The notice informed the accounts of the potential for the roll pin to break due to a combination of severe corrosion and fatigue, leading to the detachment of the hanger bar from the jib of the lift. The accounts were advised to identify if they have any Arjo Maxilift patient lifters in their facility, identify which version of Arjo Maxilift hanger bar they have using the photographs in Figures 1,2 and 3 in the letter. Any lifters found with a hanger bar attachment as shown in Figure 1 must be immediately and permanently taken out of use, as the replacement hanger bar assembly is no longer available. Any lifters with a hanger bar attachment as shown in Figure 2 must be taken out of use until a correction has been performed by ArjoHuntleigh. Any lifters with a hanger bar attachment design as shown in Figure 3 are not affected and can continue being used. The accounts were provided with a product upgrade offer and a MaxiLift Preventative Maintenance Schedule. The accounts were requested to complete and fax, e-mail or mail the enclosed Customer Response Form to Arjo at 630-925-7974 or quality@arjousa.com, indicating the number of Maxilifts in each category that they have and that the products have been taken out of service for replacement or correction, listing the model numbers and serial numbers of their lifts. Questions were directed to the ArjoHuntleigh Customer Support or Quality Department at 1-800-323-1245.

Device

Maxilift
  • Modèle / numéro de série
    All models and all serial numbers of Maxilifts manufactured prior to January 1, 1997.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Countries of USA and Mexico.
  • Description du dispositif
    Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Arjo Inc., Roselle, IL 60172; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. || The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff.
  • 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