Events

Rappel de Stockert Centrifugal Pump (SCP) Control Panel (S3)

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 Sorin Group USA, 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
    63381
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0166-2013
  • Date de mise en oeuvre de l'événement
    2012-09-20
  • Date de publication de l'événement
    2012-10-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113635
  • 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
    Control, pump speed, cardiopulmonary bypass - Product Code DWA
  • Cause
    Sorin group usa, inc. has issued an urgent field safety notice regarding certain serial numbers of the stockert centrifugal pump (scp) pump control panel . an out of specification circuit board component within the panel may lead to a malfunction consisting of a blank or flashing display. the flow and pressure display information may also be incorrect after the malfunction.
  • Action
    The firm, Sorin Group USA, Inc., sent an "URGENT FIELD SAFETY NOTICE" dated September 20, 2012 to all affected customers by certified mail. The notice described the product, problem and actions to be taken. Customers were instructed to discontinue use of and segregate affected product for return and replacement to the firm; to complete and return the attached Customer Response Form via fax to: 303-467-6502 or email to: yvonne.feyerherm@sorin.com; and if they have transferred the affected products to a third party, to pass this information to the Sorin Group. Further questions may be directed to Sorin Group Customer Service at 1-800-650-2623.

Device

Stockert Centrifugal Pump (SCP) Control Panel (S3)
  • Modèle / numéro de série
    Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.
  • Description du dispositif
    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. || The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA