Events

Retiro De Equipo (Recall) de Device Recall Innova

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
    53788
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0617-2010
  • Fecha de inicio del evento
    2009-12-22
  • Fecha de publicación del evento
    2010-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86540
  • 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
    table for x-ray system - Product Code MQB
  • Causa
    Potential table rotation of omega iv and omega v tables affecting advantx-e and innova 2000, 2100iq, 3100, 3100iq, 4100, 4100iq, 2121iq and 3131iq cardiovascular x-ray imaging systems. due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. this issue could lead to a patient fall if the unintended motion occurs during patient.
  • Acción
    Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Device

Device Recall Innova
  • Modelo / Serial
    2035762100 207662CL3 208227CATH1 208367INNOVA 212305CATH1 212604INNOVA1 214947MINNOVA 215453INNOVA21 217383CCL2A 229228INNOV21C 239436CATH4 252384CATH1 253627INNOVA1 253SAHINNOVA 262255INNOVA2 262687CL1 262687CL2 303369HCL4 303425CL3 303788CL1 303839CL2 304424INNOVA 304526INNOVA 305364P2100 305682IN2 308865GIN1 310825INNOVA21 317338CL3 317338EP1 318448INNOVA3 318449INNOVA3 330363LAB3 330375LAB2 336832MCCL6 360456XCL4 402559UCC 402559UCD 406329IN21 407321INCL2 4088852100 409938INV21 410337INNOVA6 410554INNOVA1 410554INNOVA2 414649INNOVA2 417269SCLA 417347FCV2 423495MCATH1 4436432100 479441EP 503561CL1 505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100 516562INNOVA2A 516562INNOVA3A 516562INNOVA6 516632INNOVA1 518243LAB1 541677MINNOVA2 541732CV2 573761SMC2 573815BCR2 573815BCR3 603882CATH1 607737CL1 609267IN2100 609757IN2100 610250INNOVA1 610250INNOVA3 610645LAB10 610983INNOVA2 610988INNOVA5 612273INNOVA2 615342CV3 615515OPCL 615846STJV 617525AL1 619457INNOVA5 630856H21EP 631862INNOVA 650369SV4 661BHINNOVA1 7023602100 704384CL21 704384CLEP 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 717782INNOVA21 718780CATH3 727521CATH2 727869CATH3 727869CCL2 727869EP5 732776CATH4 760JFK2100 775982INN2100 781340IN1 781340IN3 785354HRTEP 8053702100 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 814452EP 8157412100 815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB2 847316INNOVA1 858554INNOVA2 858554INNOVA3 864255SFCL1 865693CCL 865693CCL2 865977CCL 901765EP 904597CATH 910343EP2 910343NHIN3 916781INNOVA2 9284532100 937208INNOVA2 954735CL2 954987CCL8 954987CL4 970350CL2 9704CHINNOVA 973579LAB1 A5605743 CM2100 ECXV1406F FHORLCL04 FHORLEP2 FHORLEP3 LGH2100EP LVINOV7 M2068110 PRESBYDEP RPINNOVA2100 0853060193 0853060195 0853060197 0853060199 0853060203 0853060205 21007VAS01 01031VAS01 06052VAS01 09010VAS01 34134VAS02 63010VAS01 64002VAS01 80002VAS01 TN1027VA02 SY1001VA02 SY2005VA01 SK1083VA01 0847160002 0847160004 A004RX01 A020RX13 SD1038VA01 SA1011VA01 SA1054VA02 RU1047VA02 RU1295VA01 PER00218 787378INNOVA 787844INNOVACL3 600042VA03 600151VA01 PK1301VA01 0002752691 NO1009VA03 NO1238VA01 36INOVA2733687 662INNOVA21 81INOVAISSSTE08 MA1004VA02 LV4000VA02 LV4000VA03 LV4001VA02 LT4000VA04 LT4000VA05 LB1042VA01 KW1018VA05 0850060723 0850060731 YV0054 YV0055 YV0056 YV0057 YV0058 YV0060 YV0061 YV0062 YV0063 YV0064 YV0066 YV0067 YV0070 YV0074 YV0075 YV0076 YV0077 YV0078 YV0079 YV0081 YV0100 A5111034 A5129025 A5219606 A5220710 A5330714 A5333037 A5400910 A5624127 A5800506 A5807919 B5120723 B5603933 C5123625 C5123626 IR1748VA01 082416100012 082416130026 082416210007 083016002101581 083016062000898 083016066828777 083016202101917 083016242100481 083016242100487 083016242100748 083016242101839 083016282101457 083016602101807 083016802100516 08301680520687 083016822100478 083016822101187 083016842101977 083016862101407 083016862101656 083016862101916 0835160024 0843160005 0850060729 0853060191 0910162012 0910163011 IE1100VA02 0835160018 0835160021 0835160022 HU1094VA01 HU1116VA01 HU1231VA10 0828160007 2704830INNOVA H1420VAS16 H17654VAS8 H2077VAS27 00060VAS02 00060VAS03 00109VAS02 00234VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 10086VAS06 10507VAS01 B4192946 B5483438 G4191713 M1334109 M181374801 M2569315 M2569317 M2621511 M4176519 M4198195 M4200108 M4202928 M4496941 FI1025VA01 ME612436 EG1029VA01 EG1729VA01 EG1741VA01 2730923INNOVA DZ1006VA01 DZ1050VA01 DR-2737019-CO HC0222XR35 HC4348XR02 HC4355XR06 PC0016XR01 PC0052XR07 PC0052XR08 2641225INNOVA 2664023INNOVA 2696283INNOVA 2718316INNOVA 26814ANGI2 468668XR01 416864INNOVA 604682INNOVA2 604875AINNOVA1 604875AINNOVA2 082416010005 082416010007 082416030004 082416030005 082416040011 082416040012 082416040014 082416050003 082416060001 082416070006 082416100007 082416100014 082416100015 082416110005 082416120009 082416130019 082416130024 082416150002 082416160007 082416180003 082416200004 082416210011 082416220010 082416230003 082416010007 082416210010 1239682 1291396 2632834 2646154 2673668 2706080 BG4042VA01 010120RX44 110028RX15 0910162009 0910162013 0910163014 AL4009VA02 ZA2239RX01 388275617VASCTR
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.
  • Descripción del producto
    Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System
  • 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