Events

Rappel de Device Recall GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000

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
    59522
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0107-2012
  • Date de mise en oeuvre de l'événement
    2011-08-29
  • Date de publication de l'événement
    2011-10-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103010
  • 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 recently become aware that an exposed high voltage gradient wire internal to the msk 1.5t extreme system equipment may cause electrical shock, which may impact service personnel safety. this issue does not impact patient or operator safety.
  • Action
    GE Healthcare LLC sent a "Urgent Medical Device Correction letter" dated August 29, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to please ensure that all potential service personnel at your facility are made aware of this safety notification and the recommended actions. Contact your local service representative if you have any questions concerning this notification. For further questions please call ( 262 ) 513-4122.

Device

Device Recall GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000
  • Modèle / numéro de série
    06012008-001 12182008-001 12162008-001  03132009-001  03242009-001 05152009-001  07142009-001  08082009-001 09172009-001 12072009-001 10252009-001 01082010-001 012720100-001 03072010-001 03252010-001 04012010-001 05262010-001 06082010-001 06182010-001 09142010-001 11292010-001 10182010-001 12052010-001 08122009-001 09222009-001 02242010-001 10082009-001 02112010-001 10222010-001 08132009-001 12222010-001  06192009-001 10312010-001 10142009-001 09222010-001 10012009-001 06042009-001  06062009-001 09072009-001 01182010-001 03012010-001 07272010-001 09132010-001 10082010-001 11162010-001 12152009-001 12242009-001 12142009-001 04302010-001 04082010-001 05072010-001 08152010-001
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of AL, CA, FL, ID, NY, NH, NJ, NV, OH, PA, TX, VA and WI., and countries of UNITED ARAB EMIRATES, UKRAINE, UNITED KINGDOM, SWITZERLAND
  • Description du dispositif
    GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. || The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
  • 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