Events

Rappel de BHM Kwiktrak Fixed Gate

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
    36636
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0479-2007
  • Date de mise en oeuvre de l'événement
    2006-10-23
  • Date de publication de l'événement
    2007-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49038
  • 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
    patient lift component - Product Code FSA
  • Cause
    The kwiktrak gate stopper may fail and allow the ceiling lift to pass through to the end of the track and fall to the floor.
  • Action
    Arjo Inc. USA sent recall letters to the direct accounts on 10/30/06, informing them that if the ceiling lift is moved too fast or too forcefully into a closed gate, the gate stopper can be damaged, causing its function to fail. One consequence can be that the gate may remain open, allowing the ceiling lift to pass through to the end of the track. The letters requested the customer to visually inspect their Kwiktrak Gate installation used with their Maxisky-600 Ceiling Lift to determine if there are any signs of impact or burr marks on the closed gate stopper. Illustrations of a damaged and normal gate stopper were included. The customers were requested to stop use of the Kwiktrak track system if any signs of impact or burr marks are found, and contact the Arjo Quality Department at 1-800-323-1245, ext. 6140 for special instructions. If no signs of damage were found, the customers were reminded to make sure that they manually drive the ceiling lift in a gentler manner to prevent damage to the gate stopper, making sure that all personnel using the ceiling lifts are properly trained. The accounts were informed that Arjo personnel will contact them in the next few weeks to install an improved system that will eliminate the risks of failure.

Device

BHM Kwiktrak Fixed Gate
  • Modèle / numéro de série
    Part #700.11550 installed in combination with part #700.15515.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Michigan, Ohio and Illinois
  • Description du dispositif
    BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. || The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and || b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits
  • Manufacturer
    Arjo, Inc.

Manufacturer

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