Events

Rappel de Device Recall BRILLIANCE VOLUME

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
    52214
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1582-2009
  • Date de mise en oeuvre de l'événement
    2008-12-22
  • Date de publication de l'événement
    2009-06-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82541
  • 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
    Software anomaly. an artifact may appear in brain scans and brain perfusion studies, when using 80kv and a ua, ub, or uc filter with this ct scanning device.
  • Action
    An "URGENT - Field Safety Notice" dated December 22, 2009 was issued via certified mail to affected customers. The letter described the affected product, problem, hazards involved, and actions for customers to take. Philips will provide customers with a software update for all affected systems within next 6 months. The firm also sent a second notification in the form of an "URGENT -Medical Device Correction" report dated January 29, 2009 which contained information noted in the "URGENT - Field Safety Notice". Direct questions to your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.

Device

Device Recall BRILLIANCE VOLUME
  • Modèle / numéro de série
    Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.
  • Description du dispositif
    Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. || The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

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