Events

Rappel de Otto Bock Kimba

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 Bock,Otto,Orthopedic Ind,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
    27588
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0181-04
  • Date de mise en oeuvre de l'événement
    2003-10-29
  • 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
    2005-11-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30147
  • 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
    Wheelchair, Mechanical - Product Code IOR
  • Cause
    Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
  • Action
    Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers.

Device

Otto Bock Kimba
  • Modèle / numéro de série
    The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed nationwide in the United States and to Canada and Mexico.
  • Description du dispositif
    Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • Adresse du fabricant
    Bock,Otto,Orthopedic Ind,Inc, 3000 Xenium Ln N, Minneapolis MN 55441-2661
  • Source
    USFDA