Events

Rappel de Ingenia 1.5T and 3.0T MRI Systems

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
    60304
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0293-2012
  • Date de mise en oeuvre de l'événement
    2011-08-03
  • Date de publication de l'événement
    2011-11-28
  • 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=104996
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Cause
    The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to rf heating when the torso of the patient is positioned within the body coil.
  • Action
    Philips Medical Systems ( Cleveland) Inc. sent a Urgent Field Safety Notice dated August 3, 2011, to all affected customers. Philips Field Service Engineers were dispatched to the affected customer sites to deliver the recall notification and to perform the necessary software corrections. The letter lists the affected MRI systems; describes the problem; the actions to be taken by the customer/user; it also informs the customer of the upcoming software correction which will be applied to each unit by the Philips Field Service Engineers in order to address this issue. If any additional information is required, the customer is instructed to contact their local Philips Field Service Engineer. For further questions please call Customer Care Solutions Center (CCSC) at 800-722-9377.

Device

Ingenia 1.5T and 3.0T MRI Systems
  • Modèle / numéro de série
    Twelve (12) units were distributed to customers in the U.S. The recalled Serial Numbers are: 42001, 42003, 41000, 41005, 42006, 42040, 41035, 41028, 42034, 42033, 41034 and 42038.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, GA, OR, MI, NJ and TX., and the countries of AU, BE, CH, DE, FR, JP, NL and SE.
  • Description du dispositif
    Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. || This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.
  • 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