Events

Rappel de Device Recall Brilliance 64 CT XRay 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
    58510
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2206-2011
  • Date de mise en oeuvre de l'événement
    2011-03-07
  • Date de publication de l'événement
    2011-05-19
  • 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=99493
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Cause
    A program software error in the algorithm produces image artifacts that could possibly lead to a misdiagnosis of patients who have small metal implants.
  • Action
    A 'Field Safety Notice - Urgent - Medical Device Correction' notification was sent to the firm's customers via Certified mail on 3/8/2011. The notification letter explains the nature of the Metal Artifact Reduction/Metal Artifact Correction software error; the Brilliance CT X-Ray systems subject to correction and how to identify them; and the circumstances under which this error can occur. It also asks that the user stop running the MAR application on any of the affected Brilliance systems identified with the recalled serial numbers and software versions alluded to in the medical device correction notification. Lastly, the notification states that Philips Medical will provide a solution that will fix the issue and the notification lists contact names; telephone numbers; and E-mail addresses which the customer can contact for further information concerning this device issue, or customer support assistance.

Device

Device Recall Brilliance 64 CT XRay System
  • Modèle / numéro de série
    The following Serial Numbers of the Brilliance 64 (including Ingenuity CT) are subject to recall/software correction: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005, and 300010.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- DC, IL, IN, MI, MO, NY, OH, OR, PA, TX, and VT.
  • Description du dispositif
    Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028. || Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • 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