Events

Rappel de Device Recall Faaborg Person Lift, Solution/Nordic Series

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 Moving Solutions, 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
    28199
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0553-04
  • Date de mise en oeuvre de l'événement
    2004-01-21
  • 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
    2007-10-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31388
  • 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
    Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
  • Action
    Letters were sent to all Faaborg lift customers on 11/29/01 and 01/24/04 advising the users that all bolts in connection with the hanger bar must be inspected, greased and tightened, and all defective or worn down bolts and washers must be changed. The 1/24/04 letters included an upgraded maintenance schedule and an Important Service/Safety Reminder, as well as a supply of hanger bar bolt washers. Any questions were directed to Moving Solutions' Service Department at 800-228-7980. Follow-up letters were sent to the accounts on 3/11/04, referencing the 1/21/04 letter and instructing the accounts not to use the lifts until the bolts have been inspected and retrofitted with the washers. Copies of the revised maintenance schedule and operating instructions were included.

Device

Device Recall Faaborg Person Lift, Solution/Nordic Series
  • Modèle / numéro de série
    all Solution/Nordic series models, all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide to nursing homes, residential schools and home patients, and internationally to Canada.
  • Description du dispositif
    Faaborg patient lift/hoist, battery operated lifts. The Solution/Nordic series lifts have electric V-shape base widening, with a weight capacity of 210 lbs. to 365 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.
  • Manufacturer
    Moving Solutions, Inc.

Manufacturer

Moving Solutions, Inc.
  • Adresse du fabricant
    Moving Solutions, Inc., 2550 Wisconsin Ave, Downers Grove IL 60515
  • Source
    USFDA