Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, SIGNA Excite 3.0T

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 Healthcare.

¿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
    72301
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0256-2016
  • Fecha de inicio del evento
    2015-08-31
  • Fecha de publicación del evento
    2015-11-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140520
  • 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
    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.
  • Acción
    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 Excite 3.0T
  • Modelo / Serial
    00000304469MR0 910609CF3T 00000000043586 336713WFUMR 002004-0924-11 321MR3T3 2333 901726OPMR 002004-0520-05 727785MR 00000005232YR4 414649MR5 000000HDMR2722 858657MR1 1556044 9085223T 002004-0520-06 407999MR3T 002004-0805-01 8109873T 00000263655MR3 321MR3T2 00000006583YR9 HSS3T5 002005-0216-15 731425MR2 002005-0216-19 6053883T 002005-1020-30 248465MR3T 002005-0127-12 248849MR3T 002004-1117-11 916UCDMR3T 000000HDMR3737 2059393T 002005-0331-11 919684MR6 000000HDMR3654 402219MR3T 002005-0519-19 205345MR3T 000000000R3780 210921SWGMR 002005-1201-36 662MSU3T 000000HDMR5675 407303MR3T 00000267527MR0 903870VM3TMR1 000000HDMR5786 602285MR4 00000HDMR10672 ASLWEST30MR 00000269041MR0 0910272044 00000266160MR1 2550000 00000257756MR7 082427230015 00000279423MR8 082427310015 00000280319MR5 082427160051 00000280898MR8 082427100075 00000282686MR5 082427010032 00000283076MR8 082427300008 00000283386MR1 082427070048 00000265969MR6 082427040042 00000279752MR0 082427160050 00000273833MR4 M4434864 00000264643MR8 M4135138 00000838BD4EC9 A5103135 00000273267MR5 YM1408 00000267200MR4 YM1396 00000267203MR8 YM1397 00000268417MR3 YM1414 00000269575MR7 YM1403 00000270026MR8 YM1405 00000272070MR4 YM1407 00000272969MR7 YM1406 00000260692MR9 0850270170 000000HDMR3167 81MR3T2715363 00000013212GQ6 7771MREXCITE3 00000254375MR9 NPV26104 00000266826MR7 0853270071 00000269581MR5 0853270072
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
  • Manufacturer
    GE Healthcare

Manufacturer

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