Events

Rappel de Device Recall Philips Multi Diagnost Eleva II with swivel cable

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 Philips Healthcare 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
    62052
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1829-2012
  • Date de mise en oeuvre de l'événement
    2012-05-21
  • Date de publication de l'événement
    2012-06-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109739
  • 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, x-ray, angiographic - Product Code IZI
  • Cause
    Multidiagnost eleva x--ray system may have damage to system cables from repeated movement.
  • Action
    Philips Healthcare Imaging issued Urgent Field Safety Notice dated May 21, 2012, to accounts informing an inspection will be performed of the unit. The Cable guiding plate will be replaced. If the cables show any damage the complete cable set wll also be replaced. No action is be taken by the customer. For further information customers should call 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips Multi Diagnost Eleva II with swivel cable
  • Modèle / numéro de série
    Units with cable swivel delivered from 2007
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Nationwide Foreign: Australia Austria Belgium Bharain Canada China Columbia Czech Republic Denmark Dutch Antilles Egypt Estonia Finland France Germany Hong Kong Ireland Israel Italy Latvia Lebanon Luxembourg Malaysia Mexico Netherlands New Zealand Norway Philippines Qatar Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syria Taiwan Thailand Turkey United Kingdom
  • Description du dispositif
    Philips Multi Diagnost Eleva II with swivel cable || Product Codes; || 708032, 708036 || Multi Diagnost Eleva with FlatDetector with swivel cable || Product Codes: 708034, 708037 || This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA