Events

Rappel de Device Recall Phoenix x/ray v/tome/x series

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 GE Inspection Technologies, LP.

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
    52193
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1827-2011
  • Date de mise en oeuvre de l'événement
    2009-03-16
  • Date de publication de l'événement
    2011-04-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82489
  • 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
    cabinet x-ray explosive detection systems - Product Code RCE
  • Cause
    Some of the systems do not have a safety interlock on the service access panel. although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. also, some systems lack proper placement of a caution label and others do not have this label affixed. two of the systems also lack the sign indicating the meaning of the warning signals.
  • Action
    The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.

Device

Device Recall Phoenix x/ray v/tome/x series
  • Modèle / numéro de série
    All affected units.
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Phoenix x/ray v/tome/x series. || Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
  • Manufacturer
    GE Inspection Technologies, LP

Manufacturer

GE Inspection Technologies, LP
  • Adresse du fabricant
    GE Inspection Technologies, LP, 50 Industrial Park Rd, Lewistown PA 17044-9312
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA