Events

Rappel de Device Recall ACIST

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 Acist Medical Systems.

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
    64840
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1145-2013
  • Date de mise en oeuvre de l'événement
    2013-03-15
  • Date de publication de l'événement
    2013-04-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117164
  • 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
    Injector and syringe, angiographic - Product Code DXT
  • Cause
    Acist medical systems is issuing a voluntary recall notice for three specific lots of bt2000 automated manifold kits. for these specific lots, acist has received field reports related to ingress of air into the manifold body. this has been detected by the air column detect sensor halting the injection, and normally replacement of the bt2000 automated manifold kit is necessary in order to proceed w.
  • Action
    ACIST Medical Systems sent an Urgent Medical Device Recall letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to discontinue use or further distribution of the product. If you possess inventory containing any of the lot numbers listed above, please discontinue use or further distribution of these products. Please return this inventory to ACIST. Upon receipt of the returned BT2000 Automated Manifold Kits, ACIST will arrange for a shipment of replacement kits at no charge. To order additional or immediate replacement product, please contact BRACCO customer service at 1-877-BRACCO9 (1-877-272-2269), option 1. Please also complete and return the enclosed Medical Device Recall Form (see enclosure). Even if you do not possess any of the affected product in your inventory, the form needs to be completed and returned, indicating that you have no remaining units containing these lot numbers in your inventory.

Device

Device Recall ACIST
  • Modèle / numéro de série
    23884007, 23884008, 23884009
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
  • Description du dispositif
    ACIST Medical Systems Inc. || The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Adresse du fabricant
    Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344-2137
  • Société-mère du fabricant (2017)
    Bracco Spa
  • Source
    USFDA