Rappel de Device Recall Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1

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
    57077
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0476-2011
  • Date de mise en oeuvre de l'événement
    2009-08-28
  • Date de publication de l'événement
    2010-11-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    The measurement values provided by the ge workstation may be incorrect when applied to magnification images acquired on non-ge digital mammography systems. if not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion that may impact patient treatment and safety. the measurement values for ge images are not affected.
  • Action
    GE Healthcare issued "Urgent Medical Device Correction" letters dated August 28, 2009 or August 31, 2009 to either Seno Advantage Customers (Hospital Administrators/Risk Mangers, Radiology Department Managers), and Image Diagnostic Customers (Hospital Administrators/Risk Managers, Radiology Department Managers). The letters described the Safety Issue, Affected Product Details, safety Instructions, Product correction and Contact Information. GE will linstall new software with the release of Field Modification Instruction 12129. Customers can contact GE Healthcare about this issue at 800-437-1171.

Device

  • Modèle / numéro de série
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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI,MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY, and to the countries of UNITED KINGDOM, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SOUTH, KOREA, SAUDI ARABIA , PORTUGAL, NEW ZEALAND, NETHERLANDS, KUWAIT, JAPAN, ITALY, GERMANY, FRANCE , CHINA, CANADA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, VENEZUELA, UNITED ARAB EMIRATES, THAILAND, SWEEDEN, SOUTH AFRICA, SLOVENIA, SINGAPORE, RUSSIA, PHILLIPNES, NORWAY, POLAND, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LUXEMBOURG, LEBANON, JORDAN, JAMAICA, ISRAEL, IRELAND, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUADOPUO, GREECE, GEORGIA, FINLAND, EGYPT, DOMINICAN REPUBLIC, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, BULGARIA, BOTSWANA, and ALGERIA.
  • Description du dispositif
    GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
  • Manufacturer

Manufacturer

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