Events

Rappel de Device Recall Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, an

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
    64291
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0935-2013
  • Date de mise en oeuvre de l'événement
    2011-05-10
  • Date de publication de l'événement
    2013-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115767
  • 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
    An error on the sr viewer reporting tool in which edits can be made on a report and can be saved into incorrect reports.
  • Action
    GE Healthcare sent an Urgent Field Safety Notice dated May 5, 2011, to all affected customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to open only one patient report at a time when editing a report in SR Viewer. US Customers did not receive a customer letter, however all US systems have been updated. For questions customers were instructed to contact their local Sales/Service Representative. For questions regarding this recall call 262-513-4122.

Device

Device Recall Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi,...
  • Modèle / numéro de série
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF IRAN, IRAQ, ITALY, IRELAND, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, KAZAKHSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MACEDONIA, MARTINIQUE, MOROCCO, NETHERLANDS, NORWAY, PAKISTAN, PERU, PHILIPPINES, REUNION, NEW ZEALAND, OMAN, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SINGAPORE , SLOVAKIA, SOUTH KOREA, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, URUGUAY, VIET NAAM, and YUGOSLAVIA.
  • Description du dispositif
    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. || The GE Signa HDx MR system is a whole body magnetic resonance scanner.
  • 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