Events

Rappel de Device Recall AdminTool2

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
    60164
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0272-2012
  • Date de mise en oeuvre de l'événement
    2011-06-06
  • Date de publication de l'événement
    2011-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104631
  • 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
    System, image processing, radiological - Product Code LLZ
  • Cause
    Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.
  • Action
    An 'URGENT FIELD SAFETY NOTICE" was sent via FED-EX by June 6, 2011 to all the sites using the affected product. The letter described the issue and mitigation. The letter recommends that users not move reports to studies where a report already exists. If a report is being moved because the existing report is irrelevant to the study, then the existing report should be deleted prior to moving the new report to that study. If the report is being moved because the user wants to combine the content of the reports, then the "merge" function should be utilized. The letter also states that a software enhancement is currently available. Acknowledgment via FAX-Back was requested from the sites. Questions regarding the issue should be directed to customers' local Agfa HealthCare Service at 877-777-2432. The firm has identified 185 additional sites and an "URGENT FIELD SAFETY NOTICE" was sent on October 12, 2012.

Device

Device Recall AdminTool2
  • Modèle / numéro de série
    Software Versions 1.00.26, 1.00.27, CV7.4.SU3 and CV7.8.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Virgin Islands and Canada
  • Description du dispositif
    IMPAX CardioVascular (CV) Admin Tool || The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.
  • Manufacturer
    AGFA Corp.

Manufacturer

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