Events

Rappel de Minstrel Patient 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..

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
    28958
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0970-04
  • Date de mise en oeuvre de l'événement
    2004-04-30
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-08-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32871
  • 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 hanger bar may detach from the jib yoke, and the m8 bolt in the foot pedal assembly may come loose, resulting in the patient lift becoming unstable.
  • Action
    Field Correction Notification letters dated 4/30/04 were sent by certified mail to the end users, informing them of the possibility of the hanger bar assembly to detach from the jib due wear of the pivot assembly within the yoke. They were also advised that the bolt in the foot pedal assembly could come loose, rendering the lift unstable. The users were requested to inspect their lifts or take them out of service pending service by an Arjo service engineer. The users were requested to complete customer response form indicating the model numbers and serial numbers of the lifts at the facility, both in use and out of service, and either mail or fax the form back to Arjo. Within two weeks an Arjo service engineer will contact each facility to schedule an appointment to service the lifts at Arjo's expense. Any questions were directed to Don Smith, Technical Service Director, at 1-800-323-1245, ext. 6167.

Device

Minstrel Patient Lift
  • Modèle / numéro de série
    model numbers HMB001-US and HMB002-US, all units with and without scales up to and including serial number MPLAT0307W855
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, Georgia, Maryland, West Virginia, Texas, Tennessee, South Carolina, Kansas, Nebraska, Hawaii, Massachusetts, Ohio, Minnesota, Pennsylvania, Connecticut and Colorado.
  • Description du dispositif
    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Adresse du fabricant
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA