Events

Retiro De Equipo (Recall) de GE Healthcare MRI systems with Confirmas CADstream

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Medical Systems, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    53957
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0592-2010
  • Fecha de inicio del evento
    2009-10-06
  • Fecha de publicación del evento
    2010-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86946
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Ge healthcare has recently become aware that the use of confirma, inc.'s cadstream in conjunction with the ge healthcare's pure (phased array uniformity enhancement) software for dynamic mri imaging (signa excite 1.5t, signa hd 1.5t, signa hdx 1.5t, signa hdxt 1.5t, signa hde, ge discovery mr450 and the signa 3.0t mr750 mri systems ) may require a modification to the study preference settings to p.
  • Acción
    GE Healthcare issues an "Important Product Information" letter dated October 23, 2009. The letter was addressed to Hospital Administrators, Managers of Radiology and Radiologists. The letter listed the Issue, Affected Product Details, Instructions, Product correction and Contact Information. For further information, contact GE Healthcare at 1-262-548-2731.

Device

GE Healthcare MRI systems with Confirmas CADstream
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- All States in the US including DC and Puerto Rico. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, ISLAMIC IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA REPUBLIC, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, UNITED KINGDOM, UZBEKISTAN, VENEZUELA and VIETNAM.
  • Descripción del producto
    Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) || Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs 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.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

GE Medical Systems, LLC
  • Dirección del fabricante
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA