Events

Rappel de Device Recall Philips IQon Spectral CT

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 Medical Systems (Cleveland) 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
    76024
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1006-2017
  • Date de mise en oeuvre de l'événement
    2016-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151964
  • 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, tomography, computed - Product Code JAK
  • Cause
    Multiple issues have caused the device to result in ct rescans or incorrect scan location or misrepresentation of image results.
  • Action
    Philips sent a Customer Information Letter dated December 13, 2016 to customers via certified mail. The letter identified the affected product, problem and actions to be taken. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. For further information or support concerning this issue contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).

Device

Device Recall Philips IQon Spectral CT
  • Modèle / numéro de série
    System Serial Number: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860027 860028 860033 860038 860039 860040 860041 860042 860043 860026 860029 860030 860031 860032 860034 860035 860036 860037
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AR, IN, LA, MA, MN, OR, TN & TX. and the countries: Australia, Belgium, Denmark, France, Germany, Israel, Japan, Republic of Korea, Poland, Portugal, Slovenia, Switzerland, Thailand and United Kingdom.
  • Description du dispositif
    IQon Spectral CT with software version 4.7.0 || Product Usage: || The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA