Events

Retiro De Equipo (Recall) de Device Recall Definium 8000

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
    60132
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0584-2012
  • Fecha de inicio del evento
    2011-11-22
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104485
  • 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, x-ray, stationary - Product Code KPR
  • Causa
    Ge healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the definium 8000 and discovery xr650 image pasting systems that may impact patient and user safety. the patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. thi.
  • Acción
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 17, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions; discontinue use of the patient barrier and remove from service (away from patients) if either one the rotating arm locking levers is damaged (does not hold the rotating arm in place when engaged); take extra precautions to hold the patients barrier rotating arm during release of the locking lever and repositioning of the arm and store the rotating arms in the lowest pivot position (down) when not in use. The letter also stated that the patient barrier may continue to be used if the rotating arm locking lever securely holds the rotating arm in place when it is engaged. Additionally, GE Healthcare will modify the rotating arms to restore the residual friction so that the arm will retain position (rather than swing freely) while the locking levers are disengaged. Also, GE will update the product labeling to improve awareness and identify the hazard relative to proper storage. If you have any questions, call Center in US: 800-437-1171; Japan: 0120-055-919 and for other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.

Device

Device Recall Definium 8000
  • Modelo / Serial
    System ID Definium 8000  205801KDEF1 734671DEF1 205801KDEF2 336716BCR4 907580RM5 305325SM1 252847DEF6 313745ORTHO1 540536DRAD2 OCPINED8K 614566DR1 808951XRDB 315376D8K 843789VR2 419621DR 313745ORTHO2 734998ORTHO1 361572MOBD8K 478MORTHOD8K 720494D8K 559SKDHD8K 734647DEF1 SLQDEF1 212533DEF 484565DEF2 808951XRDA SCOIVALD8000 210617H122 208422D8000 512268D8000 954265ME4 216844XRD1 706721MDR2 717763MPXRD1 SLPDEF1 NYPHC370913 603225DRAD 225358DEF1 708364D8K 708202D8K2 NYPHC370910 847688DX2 928757DR3 252ECHI8K 970DOA8K 856355DEF NYPHC370911 850416DXR NYPHC370914 NYPHC370912 503387D8K 419424DR 704323M8K 315338D8K 215823DEF1 828696RM1 617739RM1D1 MCCD8K 915564DRAD 573632CROR1 304256DEF 501868ACHBR 801285DR1 937296D8K 865429DR1 908522DIF 610526DEF1 330477XRD 813844USFR1 205949DEF1 360417SQRAD1 412688RM2 330543DR1 815525DEF8K 908668DIF 216844MSIXRD2 732294DIF 650474SNCTHU5 360417SQRAD1 216844MSIXRD 617754XRD2A 210208ER 573875CRM4 712264DF8000 314577CGRM3 313745PDDEF OAASPINE 706494HC1 503216XRD1 303340DXR 814234RAD5 717761XRD1 313745ERDEF 920885DXRD 617414ACC2 239593OTS 440974XRD3 210593RAD1 573875CRM4 210396XRD1 949219RAD OAAIMAGE 706494HC2 210804RAD1 641422RM5 617667ORTHO1 412749DEF8000 814234RAD7 617667DR6 617414ACC4 217383CDEF1 617724XR2A2 504868DF 706494HC4 210489RAD1 904WSRAD1 610954DEF 904WSER1 614293D8K 601984XRD1 330455XRD 608392DEF1 715839D8000 847437GEXRD1 973971RAD2 717544HCXRD1 717544HCXRD2 432522WCDR1 228809SRER 570621DEF 319272XRD8 903GSER NYPAL240 617726XR1CP4 269789DEFINIUM 608785DEF 920965DEF 305662ER 952746XRD2 716250CH1 610378RM1 630978DEF 757466RM6 ACB21739DEF 903UTD8 850431ER1D 541677MOIDR2 724775DEF 570621DEF2 503216XRD1 412858DEF1 408363VATHU1 719553SCCD8 816234CDR4 765832WC2 901765DR 406782BODR1 305662RM3 864512EDRM2 636947DEFRM2 920965EDEF 410337ER1 801587DX2 NYP404030 801587DX3 304757DEF8000 281274THUNDER 318681SRM1 239432D8000 601968XRD1 801587DX1 228377ER 904996RAD 773STJXRD321 979282THUNDER 513247D8K 816501RAD2 863284XRD 806212DRAD 412647DEF 432685DDR1 202741XRD 718630XRD 206598UDEF245 206598UDEF204 817329D8000 816501RAD3 720225CRXRDX 240566DR1 719333DEFC 305662RM3 610886DX1 913588KUW8K 734671DWS ACB71029DEF NYPMIL3-113 360689DX 210704PDIG1 504896D8K 956323RM3 281477MWXD2 717299XRD1 860659D8000 913696CDR1 419383ORTHO3 225754DEF1 734998BWDEF 419383ORTHO1 610954DEF2 706721MDR1 330486XRD 757722C212 734936DEF1 503513XRD NYPVC113 830331DIG1 478633DF8 207283DEFRAD1 607274DRAD1 334826HCA 661SCOID8000 978774DX1 313343DEF1 973538RAD 863680RM6 2682721 517353DEF1 206598RAD1 419783DR 650696XRD2 614257D8K 614293DR 216778XRD1 920721DEF 617724XR1A2 325670DEF1 206598UDEF247 508941RM11 727767XRAY1 978466DEF1 915747ERRAD 586532D8000 314849SLO1 704783DEF2 781344XRD2 714966RM5 925939ER1 415600CALDEF 704323DEF1 COR381050 850883ER1 541743DR5 M54219 314523OD8K 412647EDR1 949759D8 505265XRM6 813879XRD 602277A2228 505265XRM4 801662DX 906225D8K 207553DEF 229DEF8000 804SMHER2 207779DEF 704783DEF5 904202ORAD 404251DEF1 650474SNCTHU2 417781SJER 281482DR1 732923DIF1 404712DEF1 719SGPDR1 760873RAD 330363R1 212241RAD1 541768RM1 334528EAORTHO 419455DR 406457HODR1 920406DEF 330558D8 734936DEF2 650497SHTHU1 216791XRD1 617889XR1CH 734930MSDEF 541267DR1 623327D8000 412784VADEF 650474SNCTHU4 573814VARAD1 407VADEF1 303399XRD8K HIP816DEF1 415UCDEFORTHO 619532DEF15 650474SNCTHU1 251415RAD 724836DEF1 321841DEF1 503732XRD 913588KD8K 281274MSD8000 904399CHEST 859313DEFB 732776D8K 812343DEF1 614293SRDR 706733VAUD2 609219D8K 704323DEF2 409839D8000 920725DEF 301295DEF8 925939ER2 SPINEDEF1 706322SFSC 517353DEF2 210638RAD3 412692ORTHO2 706787ORTHO 650474SNCTHU6 650474SNCTHU3 717544HPXRD1 JAC2W11 303651DEF2 757388RP3 706733VR6 217326CCH2 509837SDEF 337234LBJ1 503VAHD8K 412692R1 206764DEF 713441ORTHORAD 808433D8KRM4 425455PROORTHO 734998ORTHO2 404321DEF1 720225LMCD8K 239768RM1 386FHOR1 508422DEF4 210617H104 724772DEF1 218722DEF 425392PRO1 360414XRD1 985882RAD1 978XR1NS 813827DEF8K 303321XRD8K 816234COPC 360417RAD1 00100RAD05 00123RAD05 00440RAD16 00454RAD02 00356RAD07 00226RAD08 01059RAD02 00065RAD08 10563RAD03 00065RAD07 00824RAD02 00065RAD06 00521RAD05 10086RAD03 00116RAD04 00324RAD09 AE1010RX04 61007RAD02 61012RAD01 06014RAD02 856070190 426020XR03 K001RX02 M001RX32 M001RX34 O010RX07 K002RX03 CEE15654 DE641219 DEG27409 DE644605 DPN88401 MPX27410 DEN51301 FPG86423 DEN00500 DEN00300 DEN00400 FPG93006 YE626921 DEN00200 DEN00100 DPM32148 DEN00301 DEL89966 DEN00704 DE541A09 DEN00000 DEN01005 DEN00805 DEN00602 DEN01105 EP591318 FEG85904 DEN00611 DEN90700 DPM32147 DPN26321 CEL75708 CEZ08802 CE165327 CEZ04110 CE262911 DEN01708 DE203238 DPL32925 ME504381 UE535A106 NE203136 DPB15839 GEX00400 ZA1000RX05 SA2177RX01 RU1785RX02 RU1646RX03 850070809 850070813 850070760 850070763 850070767 850070773 850070766 850070778 850070751 PER64201 PER18111 PER18410 NO1015RX08 NO1108RX03 NO1052RX08 NO1016RX07 NO1077RX03 920079103 920079105 920079110 RTD0986 MQ1000RX09 JO1000RX02 WX0102 WX0210 WX0211 XK0102 WX0203 WX0202 WX0201 WX0204 WX0205 WX0206 A5102680 A5356251 A5300722 B5300707 A5115127 A5624113 B5120721 A5804416 A5814918 A5238814 A5317201 A5317202 A5164518 A5128409 C5237807 B5127421 IL1062XR11 IE1044RX01 IE1044RX02 IE1111RX01 828070118 828070120 828070121 828070125 828070124 828070109 828070113 828070117 H2009RAD35 UHAN01XR13 HC0881XR04 HROS01XR03 487692XR02 PC0362XR07 HC7048XR05 519926XR03 561559XR02 HC0399XR08 PC6132XR07 PF1000RX11 M4168064 X59007318 A4192906 P4211488 M4187723 M4202413 M1966307 B4191737 M4472226 M4195131 M4211061 M4215549 A1717401 M9164773 M2717507 M177858601 A4167326 X1135601 M4484739 M4135317 M4173815 B4195724 M4168125 M4171226 M4185525 M4467029 A190136602 M5484954 A2035104 FI1052RX02 FI1144RX01 FI1017RX01 FI1133RX01 DK1043RX03 CS1004RX05 CS1090RX02 CS1013RX07 CS1013RX06 CS1138RX01 CS1013RX08 82407210082 82407250068 82407130221 82407040419 82407070112 82407160269 82407070114 82407040429 082407120178T 82407160279 82407040366 82407040371 82407040372 82407040373 82407040374 82407040384 82407160242 82407040398 82407040393 82407160244 82407070117 82407120178 27305DEF 27305DEF2 416813DEF8000A 905883DEF3 905883DEF1 905883DEF2 902473DEF1 514338DEF2 514338DEF3 519646DEF1 709778ADEF1 709778DEF1 519534XRD2D 416756D8000 416284DEF 519376XRD1 506452RM2A 519986RAD 519376XRD2 905522DEF 519797DEF 416284DEF2 519538RAD2 204787DEF 204787DEF2 416469DEF2 514473DEF 709637DEFINIUM 506375DEF1 416469DEF2 604557RAD4 403639RAD1 604557RAD1 604557RAD3 905848DEF1 403349ARAD2 416323DEF 905848DEF2 905895DEF 506857DEF1 418276DEF8000 514431DEF 709737RAD5 709737RAD4 030240RX04 030419RX08 190059RX20 220078RX30 080041RX14 AH3403XR03 AH6834XR02 AP4502XR08 AP3408XR10 910072181 910074017 910072141 910092229 910073084 910073085 910072169 910074018 910074022 910074021 1821DEF80 3882754403XRMET
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, PORTUGAL, NORWAY, NEW ZEALAND, NETHERLANDS, MARTINIQUE, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, HONG KONG, GREECE, GERMANY, FRENCH POLYNESIA, FRANCE, FINLAND, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BOSNIA AND Herzegovina, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.
  • Descripción del producto
    GE Healthcare Definium 8000, Digital Radiographic Systems. || Revolution XR/d Digital Radiographic Imaging System with Image Pasting and Autopositioning is indicated for use in generating radiographic images of human anatomy. This device is not intended for mammographic applications.
  • 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