Events

Retiro De Equipo (Recall) de Device Recall GE Ultrasound Vivid E9

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
    67905
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1488-2014
  • Fecha de inicio del evento
    2014-03-27
  • Fecha de publicación del evento
    2014-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126587
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Causa
    Ge healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (c1-5-d, c2-9-d, ic5-9-d and m5sc-d) are incorrect. this may result in a situation where probes can overheat.
  • Acción
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 27, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Managers of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare service representative).

Device

Device Recall GE Ultrasound Vivid E9
  • Modelo / Serial
    Mfg Lot or Serial # System ID 0000000VE90667 VE9000667  0000000VE90680 VE9000680  0000000VE90878 VE9000878  0000000VE91045 VE9001045  0000000VE91821 VE9001821  0000000VE91826 VE9R001826  0000000VE92470 VE9R002470  0000000VE93780 VE9R003780  0000000VE94119 VE9R004119  0000000VE94120 VE9R004120  0000000VE94291 VE9R004291  0000000VE94521 VE9004521  0000000VE94736 VE9R004736  0000000VE94790 VE9R004790  0000000VE94876 VE9R004876  0000000VE95024 VE9R005024  0000000VE95025 VE9R005025  0000000VE95027 VE9R005027  0000000VE95028 VE9R005028  0000000VE95222 VE9R005222  0000000VE95226 VE9R005226  0000000VE95271 VE9R005271  0000000VE95302 VE9R005302  0000000VE95319 VE9R005319  0000000VE95558 VE9R005558  0000000VE95597 VE9R005597  0000000VE95599 VE9R005599  0000000VE95604 VE9R005604X  0000000VE95654 VE9005654  0000000VE95908 VE9005908  0000000VE95949 VE9005949  0000000VE95960 VE9005960  0000000VE95969 VE9005969  0000000VE96001 VE9006001  0000000VE96004 VE9006004  0000000VE96005 VE9006005  0000000VE96008 VE9006008  0000000VE96009 VE9006009  0000000VE96010 VE9006010  0000000VE96020 VE9006020  0000000VE96022 VE9006022  0000000VE96138  0000000VE96185 VE9006185  0000000VE96186 VE9006186  0000000VE96187 VE9006187  0000000VE96188 VE9006188  0000000VE96189 VE9006189  0000000VE96190 VE9006190  0000000VE96191 VE9006191  0000000VE96193 VE9006193  0000000VE96194 VE9006194  0000000VE96210 VE9006210  0000000VE96211 VE9006211  0000000VE96212 VE9006212  0000000VE96232 VE9006232  0000000VE96233 VE9006233  0000000VE96234 VE9006234 0000000VE96235 VE9006235  0000000VE96281 VE9006281  0000000VE96282 VE9006282  0000000VE96310 VE9006310  0000000VE96312 VE9006312  0000000VE96357 VE9006357  0000000VE96359 VE9006359  0000000VE96360 VE9006360  0000000VE96361 VE9006361  0000000VE96474 VE9006474  0000000VE96475 VE9006475  0000000VE96477 VE9006477  0000000VE96566 VE9006566  0000000VE96567 VE9006567  0000000VE96568 VE9006568  0000000VE96569 VE9006569  0000000VE96570 VE9006570  0000000VE96571 VE9006571  0000000VE96657 VE9006657  0000000VE96678 VE9006678  0000000VE96685 VE9006685  0000000VE96786 VE9006786  0000000VE96790 VE9006790  0000000VE96791 VE9006791  0000000VE96081 AE1405US16  0000000VE90720 911367109 0000000VE90721 911367111 0000000VE92490 0911363976A  0000000VE92575 911369282 0000000VE94465 529150US29  0000000VE96149 83099254441 0000000VE96336 83099717941 0000000VE96337 83100013639 0000000VE96338 83100014025 0000000VE96339 83100014713 0000000VE96343 83100014763 0000000VE96344 83100014862 0000000VE96345 83100014782 0000000VE96365 83100997529 0000000VE96366 83100079792 0000000VE96367 83100997315 0000000VE92794 AH4307US35  0000000VE95988 DEMOUS0118  0000000VE96082 DEMOUS0123  0000000VE96507 AH5846US26  0000000VE96509 AH4001US79  0000000VE96517 AH5846US27  0000000VE96554 AH5099US07  0000000VE96578 AH5293US14  0000000VE96579 AH5689US32  0000000VE96635 AH5402US03  0000000VE91731 110093US12  0000000VE91878 220078US29  0000000VE95567 030232US22 0000000VE96327 210001US36  0000000VE96823 110093US18  0000000VE90343 VE9VE90343  0000000VE96809 CZ4015US27  0000000VE96810 CZ4015US28  0000000VE96811 CZ4015US29  0000000VE96812 CZ4015US30  0000000VE96843 CZ4015US31  0000000VE90568 DK1058US25  0000000VE91152 DK1079US06  0000000VE91759 DK1058US26  0000000VE92228 DK1009US16  0000000VE92422 DK1085US07  0000000VE92624 DK1018US23 0000000VE93555 DK1108US17  0000000VE93557 DK1058US27  0000000VE93558 DK1086US05  0000000VE94067 DK1029US32  0000000VE94068 DK1029US31  0000000VE94069 DK1029US33  0000000VE94286 DK1018US27  0000000VE94547 DK1083US48  0000000VE94548 DK5005US13  0000000VE95783 DK1204US09  0000000VE96056 DK1058US31  0000000VE96057 DK1058US32 0000000VE96334 DK1087US15  0000000VE96577 DK1083US59  0000000VE96668 DK1009US20  0000000VE96691 DK1000US25  0000000VE96692 DK1085US10 0000000VE96709 DK1079US22  0000000VE96710 DK1079US23  0000000VE96711 DK1079US24  0000000VE96712 DK1018US28  0000000VE96763 DK1029US37  0000000VE93238 FI1003US41  0000000VE95053 FI1003US60  0000000VE95929 FI1387US45  0000000VE96453 FI1034US11  0000000VE96462 FI1000US43  0000000VE96643 FI1025US25  0000000VE96944 FI1008US05  0000000VE91314 US73018013  0000000VE91824 USM9319104  0000000VE91879 USM9483807  0000000VE92151 U257035001  0000000VE92876 U172259004  0000000VE92895 USM2376712  0000000VE93593 USM4400108  0000000VE94549 USM4202407  0000000VE94550 US20005505  0000000VE94598 U191660607  0000000VE94599 U191660608  0000000VE94600 U191660609  0000000VE94684 UM41470601  0000000VE95034 U178486402  0000000VE95181 U304151801  0000000VE95182 U304151802  0000000VE95370 U289468803  0000000VE95451 US78113506  0000000VE95495 U224933302  0000000VE95620 US78034309  0000000VE95648 US55001908  0000000VE96037 USM4400115  0000000VE96096 US67500903  0000000VE96180 U217921402  0000000VE96223 US25000605  0000000VE96236 US55554116  0000000VE96237 USM4501713  0000000VE96240 U276410803  0000000VE96398 USM1464505  0000000VE96440 U235798703  0000000VE96441 US63001301  0000000VE96624 USM4024501 0000000VE96660 US25971506  0000000VE96661 US78027123  0000000VE96735 U202809302  0000000VE96744 U347517301  0000000VE96745 U304151808  0000000VE96746 U304151809  0000000VE96747 U235798704  0000000VE96934 U230344704  0000000VE96935 U230344705  0000000VE91368 145763U004  0000000VE91496 1280997U05  0000000VE92722 112093U006  0000000VE93136 110783U036  0000000VE93992 1280997U06  0000000VE94294 102014U003  0000000VE94585 148119U004  0000000VE95506 149657U047  0000000VE95971 110783U038  0000000VE95972 110783U039  0000000VE95973 110783U040  0000000VE95974 110783U041  0000000VE95975 110783U049  0000000VE95976 110783U046  0000000VE95977 110783U052  0000000VE96197 110395U003  0000000VE96239 122019U154  0000000VE96386 110016U020  0000000VE96387 110277U002  0000000VE96388 1280997U08  0000000VE96410 145769U013  0000000VE96411 2264533U02  0000000VE96412 110052U022  0000000VE96413 112032U009  0000000VE96414 144523U006  0000000VE96422 1882626U21  0000000VE96423 1937574U17  0000000VE96424 145100U030  0000000VE96425 3475651U01  0000000VE96483 122109U071  0000000VE96726 1685347U18  0000000VE96728 109045U026  0000000VE96729 389839U003  0000000VE96737 105827U369  0000000VE96738 105827U370  0000000VE96739 389502U011  0000000VE96740 113467U005  0000000VE96741 103302U055  0000000VE96970 TP2467U001  0000000VE92175 1519325087 0000000VE92409 1500666946 0000000VE94499 1975347812 0000000VE94500 00033ULT10  0000000VE95209 00192ULT35  0000000VE95658 143030209 0000000VE96017 172863842 0000000VE96026 124383452 0000000VE96029 172863846 0000000VE96030 172863850 0000000VE96031 172863854 0000000VE96238 1942347245 0000000VE96417 131842062 0000000VE96418 142787282 0000000VE96446 113363002 0000000VE96447 194674632 0000000VE96461 152033592 0000000VE96465 113587062 0000000VE96576 186696112 0000000VE96593 175744912 0000000VE96594 175744924 0000000VE96609 128549752 0000000VE96610 103660948 0000000VE96612 114391312 0000000VE96613 114391316 0000000VE96626 131680572 0000000VE96639 128549772 0000000VE96640 139515512 0000000VE96641 114392062 0000000VE96650 1942347598 0000000VE96695 103535162 0000000VE96730 1942555904 0000000VE96731 1793709237 0000000VE96840 IE1560US14  0000000VE96893 156706072 0000000VE96913 174072702 0000000VE93278 83038829010513 0000000VE95537 83038829553713 0000000VE96557 83037001070513 0000000VE96611 IE1199US03  0000000VE91149 A5320150  0000000VE91360 A5672210  0000000VE96331 A5174260  0000000VE96527 A5529128  0000000VE90202 UY9007  0000000VE90260 UY9016  0000000VE90621 UY9060  0000000VE90645 UY9057  0000000VE90646 UY9056  0000000VE90722 UY9070  0000000VE90725 UY9066  0000000VE90726 UY9067  0000000VE91230 UY9116  0000000VE91591 UY9134  0000000VE91610 UY9136  0000000VE92296 UY9186  0000000VE93638 UYA278  0000000VE93641 UYA281  0000000VE93656 UYA276  0000000VE93966 UYA297  0000000VE93984 UYA303  0000000VE93985 UYA300  0000000VE94031 UY9301  0000000VE94032 UY9302  0000000VE94449 UY9332  0000000VE94530 UYA340  0000000VE94663 UY9343  0000000VE94761 UY9356  0000000VE94767 UYZ354  0000000VE94988 UY9380  0000000VE95011 UY9387  0000000VE95014 UY9390  0000000VE95472 UY9411  0000000VE95521 UY9412  0000000VE95522 UY9415  0000000VE95523 UY9417  0000000VE95524 UY9418  0000000VE95525 UY9419  0000000VE95527 UYA423  0000000VE95580 UY9422  0000000VE95737 UY9426  0000000VE95832 UY9434  0000000VE95861 UY9448  0000000VE95863 UY9431  0000000VE95887 UY9440  0000000VE95897 UY9445  0000000VE95898 UY9447  0000000VE95899 UY9449  0000000VE96134 UY9450  0000000VE96135 UY9456  0000000VE96136 UY9457  0000000VE96137 UY9458  0000000VE96139 UY9473  0000000VE96164 UY9466  0000000VE96165 UY9476  0000000VE96166 UY9471  0000000VE96167 UY9482  0000000VE96168 UY9477  0000000VE96201 UY9479  0000000VE96202 UY9467  0000000VE96203 UY9468  0000000VE96204 UY9469  0000000VE96205 UY9470  0000000VE96246 UY9453  0000000VE96247 UY9459  0000000VE96248 UY9474  0000000VE96249 UY9454  0000000VE96252 UY9455  0000000VE96253 UY9460  0000000VE96262 UY9461  0000000VE96288 UY9464  0000000VE96289 UY9472  0000000VE96290 UY9462  0000000VE96291 UY9465  0000000VE96292 UY9490  0000000VE96293 UY9493  0000000VE96373 UY9491  0000000VE96380 UY9475  0000000VE96466 UY9483  0000000VE96467 UY9496  0000000VE96468 UY9484  0000000VE96469 UY9478  0000000VE96470 UY9485  0000000VE96471 UY9497  0000000VE96558 UY9486  0000000VE96559 UY9487  0000000VE96605 UY9495  0000000VE96606 UY9488  0000000VE96607 UY9492  0000000VE96608 UY9489  0000000VE96779 UY9501  0000000VE96780 UY9502  0000000VE96781 UY9503  0000000VE96783 UY9505  0000000VE96784 UY9506  0000000VE96785 UY9507  0000000VE96829 UY9508  0000000VE96830 UY9509  0000000VE96832 UY9521  0000000VE96858 UY9512  0000000VE96859 UY9511  0000000VE96860 UY9510  0000000VE96861 UY9513  0000000VE96862 UY9518  0000000VE96890 UY9519  0000000VE96907 UY9522  0000000VE96917 UY9516  0000000VE96919 UY9517  0000000VE96920 UY9520  0000000VE94450 850370200 0000000VE96297 HDW02402  0000000VE92970 920369512 0000000VE90124 NO4153US04  0000000VE90447 NO4146US07  0000000VE91393 NO4011US82  0000000VE92941 NO4070US26  0000000VE94749 NO4016US63  0000000VE94750 NO4016US62  0000000VE95151 NO4011U136 0000000VE95293 NO4000US33 0000000VE95608 NO5005US42  0000000VE96195 NO4064US16 0000000VE96209 NO4013US04 0000000VE96217 NO4088US43 0000000VE96218 NO4088US44 0000000VE96335 NO4088US46 0000000VE96399 NO4155US04 0000000VE96644 NO4068US72  0000000VE96707 NO4068US73  0000000VE96755 NO4071US08  0000000VE96756 NO4110US09  0000000VE96714 PL3169US01  0000000VE95268 PER28513 0000000VE96757 PER43240  0000000VE96828 PER02553  0000000VE96931 PES16600  0000000VE96169 RU8488US01 0000000VE96216 6073UL0050  0000000VE96911 ZA2561US23  0000000VE96200 UE255934  0000000VE94024 R002US41  0000000VE95588 M047US02  0000000VE96058 FA50US57  0000000VE96627 N004US10  0000000VE96767 A022US36  0000000VE96844 G002US07  0000000VE96845 G002US06 0000000VE96847 G001US18  0000000VE90483 534551US01  0000000VE90547 547150US03  0000000VE91374 529170US09  0000000VE91375 830593US03  0000000VE92013 475200US24  0000000VE92038 720050US05  0000000VE92226 748253US01  0000000VE93801 482896US03  0000000VE94437 260010US31  0000000VE94660 475200US31  0000000VE95592 900010US68  0000000VE95738 266210US04  0000000VE95896 529050US19  0000000VE95927 260010US36  0000000VE96048 124057US01  0000000VE96151 103000US06  0000000VE96332 850020US31  0000000VE96333 529230US13  0000000VE96439 707220US05  0000000VE96672 850010US07  0000000VE96702 506463US03  0000000VE96808 534551US02  0000000VE96815 527356US02  0000000VE94534 853380306
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of: CA, CO EL, GA, IN, KS, KY , LA, MA, MI, MO, MT, NY, NM, NV, US: OH, TX, VA, WI. OUS: ARABIC EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, COLOMBIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, INDIA,IRELAND, ITALY, JAPAN, KOREA, NETHERLAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN.
  • Descripción del producto
    GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.
  • 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