Events

Rappel de Device Recall Maquet HL Console for Heart Lung Machine HL20

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 Maquet 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
    59577
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3084-2011
  • Date de mise en oeuvre de l'événement
    2011-06-20
  • Date de publication de l'événement
    2011-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103140
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Cause
    Maquet hl 20 twin pump modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.
  • Action
    Maquet sent a PRODUCT RECALL NOTIFICATION LETTER/return response forms, dated June 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until a software update was performed by their trained technicians. Customers were also asked to forward the information contained in the notification letter to all users and to all appropriate Biomedical Staff. Customers were instructed to acknowledge receipt of the notification letter by completing and faxing back the attached response form to 973-807-9210 whether or not they have any of the affected product. For questions customers were instructed to contact their local MAQUET representative. For questions regarding this recall call 973-709-7994.

Device

Device Recall Maquet HL Console for Heart Lung Machine HL20
  • Modèle / numéro de série
    510K Number: K943803 Device Listing No.E614811 HL 20 4-umps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Maquet HL Console for Heart Lung Machine HL20 || HL 20 4-pumps console base: P/N 917741 || HL 20 5-pumps console base: P/N 917751 || Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Adresse du fabricant
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA