Events

Rappel de Device Recall GE Healthcare, SIGNA 3.0T

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.

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
    72301
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0255-2016
  • Date de mise en oeuvre de l'événement
    2015-08-31
  • Date de publication de l'événement
    2015-11-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140519
  • 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
    When performing head or neck scans, the currently displayed sar values could be lower than the actual sar in the head as predicted by sar modeling. the predicted head sar value from the modeling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare, SIGNA 3.0T
  • Modèle / numéro de série
    00000262893MR1 520694MR3 00000GE0206027 082427040020 00000243366MR2 082427040040 00000256194MR2 409740MR01 00000261205MR9 083027828659711 00000280097MR7 IE1111MR01 00000189273MR6 A5155133 00000272076MR1 YM0222 00000267372MR1 YM0333 00000000004230 YM0451 00000271322MR0 0850270094 00000227450MR7 333MR3TXXX 00000271777MR5 5606MRS3T 00000273539MR7 570844HCM3T 00000227450MR7 333MR3T 000000HDMR5684 CEN03406 00000GE0209032 0853270052IB1 00000260651MR5 10491MRS01
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
  • Description du dispositif
    GE Healthcare, SIGNA 3.0T. || Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.
  • Manufacturer
    GE Healthcare

Manufacturer

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