Events

Rappel de Skintact Electrodes for Defibrillation

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 Leonhard Lang Medizintechnik GmbH.

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
    75181
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0004-2017
  • Date de mise en oeuvre de l'événement
    2016-09-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149595
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    There is a risk that defibrillation electrodes model df29n will be connected with the defibrillator welch allyn aed 10 only with delay or not at all. this may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
  • Action
    Consignees was sent via e-mail a Leonhard Lang "Important Safety Notice" dated September 1, 2016. The letter described the product being recalled, Description of the defect, Actions and time frame of the recall, & Compensation for the recalled electrodes. Advised consignees to inform all users within their organizations of the recall; and, secure and destroy the unused electrodes in their inventory. Confirmation of destruction can be done by completing and returning the "Confirmation of Destruction / Consumption" form by October 14, 2016. If the product was further distributed, they were to forward a copy of the Safety Notice. For questions contact sales staff.

Device

Skintact Electrodes for Defibrillation
  • Modèle / numéro de série
    US: 60602-0774; 60502-0779; 60308-077; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 50130-0777; 41023-077; 41008-0778; 40730-0778; 40618-0778; and, 40130-0776. Outside US: 60725-0774; 60620-0776; 60602-0774; 60502-0779; 60308-0771; 60114-0773; 51023-0775; 50904-0777; 50403-0778; 40827-0777; 40730-0778; 40618-0778; and, 40130-0776.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland.
  • Description du dispositif
    Skintact Electrodes for Defibrillation, DF29N. || Product Usage: || Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
  • Manufacturer
    Leonhard Lang Medizintechnik GmbH

Manufacturer

Leonhard Lang Medizintechnik GmbH
  • Adresse du fabricant
    Leonhard Lang Medizintechnik GmbH, Archenweg 56, Innsbruck Austria
  • Source
    USFDA