Events

Rappel de Device Recall GE Healthcare Discovery MR450 1.5T

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 GE Healthcare, LLC.

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
    57270
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1376-2011
  • Date de mise en oeuvre de l'événement
    2010-11-18
  • Date de publication de l'événement
    2011-02-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95714
  • 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
    Ge healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your mr750, mr450, and mr450w mr systems that may impact service or maintenance personnels safety. the gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the grad.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.

Device

Device Recall GE Healthcare Discovery MR450 1.5T
  • Modèle / numéro de série
    00000XRMBB0091 00000XRMBB0101 00000XRMBB0096 00000XRMBB0111 00000XRMBB0100 00000XRMBB0063 00000XRMBB0094 00000XRMBB0099 00000XRMBB0121 00000XRMBB0122 00000XRMBB0125
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, EHYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, ITALY, JAPAN, KUWAIT, QATAR, REPUBLIC OF KOREA, SWITZERLAND, TAIWAN, and the UNITED KINGDOM.UNITED KINGDOM, TAIWAN, SWITZERLAND, REPUBLIC OF KOREA, QATAR, KUWAIT, JAPAN, ITALY, INDIA, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, CANADA, BRAZIL, AUSTRALIA.
  • Description du dispositif
    GE Healthcare Discovery MR450 1.5T, || The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used; The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA