Events

Rappel de Device Recall Ingenuity CT system

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
    59887
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0779-2012
  • Date de mise en oeuvre de l'événement
    2011-08-29
  • Date de publication de l'événement
    2012-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103937
  • 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 errors. a number of non-conformances were logged during in-house testing and external validation testing of brilliance 64, brilliance big bore, and ingenuity ct systems, equipped with software version 3.5 beta 2. the non-conformances are due to software errors identified in these device systems.
  • Action
    Philips sent an "URGENT - Medical Device Correction" notification letters to all affected customers via Certified mail on October 19, 2011. The letter describes the referenced software issues; provides instructions to the customers as to what they can do in order to address these issues; and informs the customers of the firm's upcoming software field/correction. The letter states that a Philips representative will be contacting all affected customers to install the necessary software upgrade through a Field Change Order. This will be implemented free of charge. For information or support contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solution Center 1-800-722-9377, option 5.

Device

Device Recall Ingenuity CT system
  • Modèle / numéro de série
    Model #728326, Serial Numbers: 300003, 300004, and 300005.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide (USA) including the states of: IN, MI, MO, NY, OH, and OR and the countries of Germany, Israel and Netherlands.
  • Description du dispositif
    Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. || Product Usage: The Brilliance Big Bore 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 difference angles 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