Events

Rappel de Device Recall Brilliance BigBore Oncology 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
    76683
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1492-2017
  • Date de mise en oeuvre de l'événement
    2017-02-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153824
  • 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
    When the user performs a retrospective respiratory gated 4d ct scan with the bellows pulmonary gating device, the ct images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
  • Action
    Philips sent an Urgent Field Safety Notice dated February 24, 2017, to all affected consignee's via certified mail with returned receipts for tracking purposes. Philips Key Market representatives will distribute the notices internationally. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Implementation of the software update will be monitored. Consignees requiring further information or support concerning this issue were instructed to contact their local Philips representative. For North America and Canada, contact the Customer Care Solutions Center at 1-800-722-9377.

Device

Device Recall Brilliance BigBore Oncology CT
  • Modèle / numéro de série
    System Serial Number - 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
  • Description du dispositif
    Brilliance BigBore Oncology CT - 728243 || Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. 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