Events

Retiro De Equipo (Recall) de Device Recall GE Healthcare, AW Server.

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, 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
    64900
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1137-2013
  • Fecha de inicio del evento
    2012-06-28
  • Fecha de publicación del evento
    2013-04-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117349
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    Ge healthcare has recently become aware of a potential safety issue with respect to the results viewer in the aw server. after starting the results viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. this occurs on an occasional basis, when multiple users are simultaneously accessing the results viewe.
  • Acción
    GE Healthcare sent an "Important Product Information" letter dated June 27, 2012. The letter was addressed to Hospital Administrators , Radiology Managers and Risk Managers. The letter described the Subject, Instructions and Affected Product Details. GE Healthcare will correct all affected product by providing a software upgrade at no cost. For questions call: US 800-437-1171, Japan 0120-055-919, and/or local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare, AW Server.
  • Modelo / Serial
    Mfg Lot or Serial # 00000267104GE8 00000276601GE2 00000211976GE6 00000223238GE7 00000257702GE1 00000183554HP5 00000248244GE6 000001010056GS 00000256021GE7 00000240706GE2 00000223235GE3 00000218205GE3 00000216337GE6 00000266111GE4 00000223234GE6 00000276603GE8 00000275004GE0 00000183573HP5 00000183555HP2 00000235884GE4 00000240705GE4 00000222533GE2 00000218207GE9 00000257708GE8 00000275003GE2 00000261642GE3 00000214206GE5 00000214821GE1 00000266112GE2 00000217429GE0 00000240703GE9 00000257707GE0 00000219371GE2 00000235886GE9 00000217427GE4 00000216338GE4 00000183518HP0 00000271798GE1 00000214817GE9 00000216334GE3 00000235885GE1 00000183570HP1 00000216331GE9 00000183568HP5 00000267105GE5 00000217428GE2 00000211978GE2 000001010012GS 00000240704GE7 00000229339GE7 00000216340GE0 00000266110GE6 00000267106GE3 00000260456GE9 00000222536GE5 00000261644GE9 00000214818GE7 00000183562HP8 00000229342GE1 00000276070GE0 00000235883GE6 00000257711GE2 00000257706GE2 00000222535GE7 00000260457GE7 00000246497GE2 00000246500GE3 00000211977GE4 00000261646GE4 00000183557HP8 00000183561HP0 00000213558GE0 00000183558HP6 00000183567HP7 00000223243GE7 00000223240GE3 00000240707GE0 00000216336GE8 00000276602GE0 00000218090GE9 00000L03F0BD38 00000211975GE8 00000276600GE4 00000222534GE0 00000229343GE9 00000219372GE0 00000209172GE6 00000214205GE7 00000261648GE0 00000217426GE6 00000248243GE8 00000223236GE1 00000240708GE8 00000256014GE2 00000213559GE8 00000229341GE3 00000183563HP6 00000183565HP1 00000F11206004 00000B12048002 00000E11026006 0000AB11054001 0000AA11157008 00000E11301005 00000LFB4BA808 00000M11284003 0000AX11314002 00000P10347012 000001010007GS 00000A12038004 0000AX11314001 000001010009GS 000001010008GS 000001010052GS 00000L11074001 00000260454GE4 00000183571HP9 00000218206GE1 00000229344GE7 00000248248GE7 00000267107GE1 00000261643GE1 00000261650GE6 00000257705GE4 00000223239GE5 00000183515HP6 00000183574HP3 00000246496GE4 00000248245GE3 00000261649GE8 00000257710GE4 00000248246GE1 00000217425GE8 00000267109GE7 00000260459GE3 00000183523HP0 00000261647GE2 00000248247GE9 00000216332GE7 00000214819GE5 00000217424GE1 00000260458GE5  0000AD11138001 00000E11301002 00000A12034003 00000Q11340005 00000Q11333003 00000P10312004 0000AD12016003 00000P10347001 00000B12002005 0000AD11087002 00000U11318005 0000AA11157003 0000ZA10286001 00000A12034002 00000Z10335005 00000A12034005 0000AA11157002 0000AD11087004 000001010031GS 00000C11263001 00000183537HP0 00000B12002004 00000LFB451FCA 00000183532HP1 000001010050GS 00000L11074005 00000P11244007 00000H12118002 00000C11263004 00000P11244006 00000Z10335007 00000Y11013005 00000P11244004 00000183552HP9 000001010030GS 00000P10312003 00000Z10335001 00000183528HP9 00000183506HP5 0000AA11157006 00000P10312005 00000K11152005 00000F11236001 00000183527HP1 00000A11096001 000001010028GS 00000L7B2CA730 00000F11206005 00000P11244011 000001010020GS 00000M12067008 000001010033GS 00000183540HP4 00000183530HP5 00000V11185003 00000M12067001 000001010015GS 00000E11026007 00000P11244009 000001010048GS 00000B12048003 00000183502HP4 00000M11284010 000001010037GS 00000K11152004 00000A11096007 00000Y11013010 00000F11206001 00000M12067011 00000183579HP2 000001010039GS 00000Y11013002 00000B12048005 00000183543HP8 00000U11318008 000001010049GS 00000V11136001 00000E11026010 00000V11136006 0000ZA11257001 00000V11185005 0000AA11157005 00000183510HP7 0000AA11157001 00000M12067003 000001010055GS 00000K11152007 000001010035GS 00000L11357001 00000M11284004 00000B12002003 00000183539HP6 00000E11301003 00000183501HP6 00000K11152006 00000P11244010 00000183497HP7 00000P11244003 00000F11206006 00000183581HP8 00000P10347004 00000K11152001 00000183577HP6 000001010046GS 00000K11152003 00000M11284012 00000V11136009 00000M11284011 00000LFB481AD4 00000P10312007 000001010036GS 00000L327C9590 00000A11096005 000001010054GS 00000V11136002 00000B12002002 00000E11026003 00000F11250001 00000M11284009 00000183578HP4 00000E11026001 00000E11026004 0000AA11157010 0000AA11157007 00000V11136007 00000LFB441084 00000G10363001 000001010038GS 000001010047GS 00000M12067010 00000A12034001 00000LCEFC4168 00000Z10335003 00000E11026005 00000P11244001 0000AD11138005 000001010026GS 00000Z10335004 00000K11230001 00000P10312001 0000AB10329001 00000Y11013007 000001010013GS 0000AB10329003 00000Z10335008 000001010061GS 00000Y11013008 00000J11056003 000001010001GS 00000B12048006 00000M12067009 000001010002GS 00000P10312002 00000P10347009 00000E11026008 00000P10347011 000001010027GS 00000J11056002 00000E11026002 00000E11026009 00000V11136005 00000F11206002 00000Y11013003 00000P11244013 00000J11056004 00000J11056001 0000ZA11257002 00000K11152002 000001010059GS 00000P11244012 00000E11301009 00000B12002001 00000183514HP9 0000AB10329002 000001010016GS 00000Z10335006 00000M11284013 000001010022GS 00000K11199001 00000C11263003 000001010017GS 00000B12048001 00000M12067002 00000M12067006 00000Q11340004 00000Z10335010  000001010018GS 00000L327C4AD6 00000183531HP3 00000V11185001 00000LE23E90E2 00000LE23E90CA 00000LE23E9026 00000A11096006 00000F10363001 00000LE23E8FDA 00000LE23E65BA 00000LCEFC3016 0000AD11087003 000001010044GS 000001010043GS 000001010042GS 00000K12010004 00000E11301007 00000LE23E65AE 00000L327C4A0E 0000AD12016001 00000LE23E9072 00000M11284001 00000E11301010 00000L3FE006EE 00000U11318007 00000A11096002 0000AD11138002 000001010004GS 00000P10347007 00000L11074007 0000AB11054004 0000AD11087001 00000L11074003 0000AD11104001 00000U11318003 000001010003GS 00000L11074009 0000AB11054002 0000AD11104003 0000AD11104002 00000L11071009 00000A11096004 00000B12048004 00000L11074002 0000AB11054005 000001010005GS 00000B12048010 00000J11056005 00000A12038003 00000M11284002 00000L11074004 00000A12159010 00000V11185002 00000267110GE5 00000P10312008 00000P10347003 00000L11074006 00000Q11340003 0000AA11157004 00000A11096003 00000E11301008 00000M11284006 00000S12045001 00000L11074010  00000M11284008 000001010041GS 00000L8B2FAE2A 00000H12118001 00000P10312010 00000V11136003 00000B12048009 00000Q11340002 00000E11301001 00000F11206003 000001010024GS 00000B12048007 00000Y11013001 00000Z10335002 000001010040GS 00000B12048008 00000Q11340001 0000AM11360001 00000M12067007 00000P10347005 00000P11244008 000001010045GS 0000AM11360002 0000AX11314004 00000Q11333002 00000B12002006 00000A11096009 00000P10347010 0000AB11054003 00000Y11013009 00000M11284005 0000AD11104004 0000AD11104005 00000L7B3745A8 USE152PED2  000001010023GS
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide including the states of: AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, LA, MD, MI, ,N, ,S, MO, MT, NJ, NM, NY, NC, OH, OK, PA, SC, SD, TN,TX, UT, VA, WA, WI. and the countries of : AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA, BRAZIL, CANADA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KOREA, LIBYA, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, POLAND, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY and UNITED ARAB EMIRATES.
  • Descripción del producto
    GE Healthcare, AW Server. || Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

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