Events

Rappel de Device Recall Angiomat Illumena

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 Mallinckrodt 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
    39408
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0056-2008
  • Date de mise en oeuvre de l'événement
    2007-08-24
  • Date de publication de l'événement
    2007-10-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55428
  • 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
    Illumena Injector with Auxiliary Console, - Product Code DXT
  • Cause
    Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv.
  • Action
    On 9/20/2007, a notification was sent from Mallinckrodt to all direct accounts via certified mail. The notification details the potential for mis-synchronization of injection parameters if the main and auxiliary consoles are simultaneously programmed. The notification reminds end-users that simultaneous programming should not be performed and to ensure it is not performed, a notification label (provided in the notification) is to be affixed on both consoles of the injector system. Once the label is affixed to the system, end-users are instructed to complete the notification survey and return the survey to the Mallinckrodt. In addition, the notification includes an updated chapter insert (Chapter 11.1) for the injector system's product manual that emphasize the separation between programming of the main and auxiliary consoles. Questions regarding this matter may be directed to Mallinckrodt's Product Monitoring Department at 1-888-744-1414, menu option 1 and then menu option 2.

Device

Device Recall Angiomat Illumena
  • Modèle / numéro de série
    Product Model Numbers : 902040; 904045; and 902045CI
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide to include:U.S.A. states of - AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, & WI. and Foreign countries of Argentina, Belgium, Brazil, Canada, Germany, Japan, Singapore, & Zambia.
  • Description du dispositif
    Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Adresse du fabricant
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA