Events

Rappel de Device Recall Agfa IMPAX HeartStation ECG Management System

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 AGFA Corp..

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
    53604
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0366-2010
  • Date de mise en oeuvre de l'événement
    2009-05-07
  • Date de publication de l'événement
    2009-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85969
  • 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
    electrocardiograph - Product Code LLZ
  • Cause
    Heartstation does not refresh content changes to the pdf reports that are printed emailed or faxed from the index page. this may lead to a discrepancy in patient demographics between what is displayed in the heartstation client interface and the report delivered to the consumer. questions are being directed to the local agfa representative; the contact information was included in the letter.
  • Action
    An Urgent Safety Notice was sent via FED-EX to all the sites with the affected units (a total of 6) on May 7, 2009. The three foreign accounts were notified by letter on May 14, 2009. The letter describes the potential issue and mitigation. Acknowledgment via FAX-Back that the information was received and understood was requested from the sites. Customers who use the print, email, fax functionality of this product were verbally notified of the defect and they have been advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the recommended workaround. The workaround is to only print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does not allow the user to print batches of reports as does the Index screen. Questions about this matter are being directed to the local Agfa HealthCare representative.

Device

Device Recall Agfa IMPAX HeartStation ECG Management System
  • Modèle / numéro de série
    Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
  • Description du dispositif
    AGFA IMPAX HeartStation ECG Management System.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Adresse du fabricant
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA