Events

Rappel de Device Recall superDimension Bronchus System

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 SuperDimension, 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
    36947
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0666-2007
  • Date de mise en oeuvre de l'événement
    2006-11-29
  • Date de publication de l'événement
    2007-03-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-11-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49649
  • 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
    endoscopic loacalization system - Product Code JAK
  • Cause
    The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superdimension bronchus system was used. the biopsy results for the patient were taken from a different area than the confirmed navigation site that was indicated by the system.
  • Action
    An Urgent Medical Device Field Action letter, dated 11/30/2006, was sent to medical facilities who have the superDimension Bronchus System installed. The letter infoms the facility to immediately stop using the Bronchus System, and move all inventory of the disposable system components to a controlled quarantine area. A superDimension representative will contact the consignees to schedule a time to retrieve the quarantined inventory, at which time a verification form will be completed.

Device

Device Recall superDimension Bronchus System
  • Modèle / numéro de série
    superDimension Bronchus System with the following serial numbers: S0030019, S030051, S030052, S030054, S030055, S030058 thru S030062, S030067, S030068, S030077 thru S030081; S030084, S030085, S030088 thru S030095; S030097 thru S030100, S030103, S030104, S030105, S030390, S030447, S030449, S0030009, S0030011, S0030013, S0030014, S0030015, S0030021, S0030022, S0030026, S0030042, S030043 thru S030050, S030053, S030056, S030057, S030063, S030064, S030066, S030069 thru S030076, S030082, S030086, S030087, S030096, S030102, S030477.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Austria, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Switzerland, Turkey, and United Kingdom.
  • Description du dispositif
    superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.
  • Manufacturer
    SuperDimension, Inc.

Manufacturer

SuperDimension, Inc.
  • Adresse du fabricant
    SuperDimension, Inc., 161 Cheshire Lane North, Suite 100, Minneapolis MN 55441
  • Source
    USFDA