Events

Rappel de Brilliance 64 and Ingenuity 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
    69045
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2664-2014
  • Date de mise en oeuvre de l'événement
    2011-09-01
  • Date de publication de l'événement
    2014-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129396
  • 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
    During a field test (a customer external evaluation period), the customer detected a problem in the cirs 4.0 beta 2 software. when using the cirs 4.0 beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. philips has disabled this feature at all sites evaluating 4.0 beta 2 software. philips will issue a software up.
  • Action
    The firm, Philips, sent a Field Safety Notice (FSN 72800534) entitled "URGENT-Medical Device Correction" dated September 1, 2011 via mail on September 6, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to review the following information with all members of your staff who need to be aware of the contents of this communication and retain a copy with the equipment Instructions for Use. A Field Service Engineer will visit each site to install the corrected software. If you need any further information or support concerning this issue, please 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, option 5: Enter Site ID or follow the prompts).

Device

Brilliance 64 and Ingenuity CT
  • Modèle / numéro de série
    91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
  • Description du dispositif
    The Brilliance 64 and Ingenuity CT are 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 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 Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA