Events

Rappel de Device Recall GE Healthcare Precision 500D

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67401
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1078-2014
  • Date de mise en oeuvre de l'événement
    2014-01-20
  • Date de publication de l'événement
    2014-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125398
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Cause
    Ge healthcare has recently become aware of a software issue associated with patient selection from the worklist on your wdr1(precision 500d and proteus xr/a equipped with wireless digital radiography option) that may impact patient safety. intermittently when a large number of patient exams are retrieved from the his/ris system, the exams when displayed on the wdr1 are not properly displayed. i.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated January 20, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information ( In USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative).

Device

Device Recall GE Healthcare Precision 500D
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1 00000075984HL5 LLPM500D 00000076011HL6 434654RM4 00000076012HL4 585596FPD1 00000076013HL2 520GV500D 00000076014HL0 781624HSSHFP 00000076015HL7 954JDCHWDR1 00000076016HL5 503391SKY 00000076018HL1 954JDCHWDR2 00000076019HL9 518926DRRM4 00000076021HL5 954265WDR1 00000076022HL3 207795CM3WDR 00000076023HL1 719285P500 00000076026HL4 540DALEVILLE 00000076027HL2 410392RAD 00000076028HL0 318495WDR1 00000076285HL6 0002952447 00000076286HL4 918579PROTEUS 00000076287HL2 518926FLRM3 00000076288HL0 ORMCP500DIG 00000076290HL6 713791P500FP4 00000076379HL7 518243WDR1 00000076380HL5 504873FP1 00000076381HL3 435722GDXR 00000076487HL8 989224FLSHPD1 00000076489HL4 229924P500 00000076490HL2 405752RF2 00000076643HL6 COR481360 00000076644HL4 713UTPROTEUS 00000076646HL9 518243WDR1 00000076647HL7 706754EF1 00000076648HL5 COR481360 00000076649HL3 518243WDR1 00000076650HL1 918273CNNP1 00000076651HL9 918434P500 00000076652HL7 714827P500 00000076986HL9 325574WDRRM2 00000076990HL1 878WDR 00000076991HL9 919RALCPFLASH2 00000076995HL0 912384FP5 00000076996HL8 540829RF1DR 00000076997HL6 305LEON27FLGD 00000076998HL4 205877BPRF1 00000077642HL7 989224FLSHPD1 00000077644HL3 240566EDWDR1 00000077647HL6 925370PAD 00000077648HL4 603524500D 00000077649HL2 618443SFP 00000077652HL6 540CULRF2 00000077653HL4 501202WDR14 00000078002HL3 760873FP2 00000078196HL3 318259RM2 00000078201HL1 757736WDR1 00000078669HL9 419538RAD 00000078670HL7 601928PXR 00000078671HL5 512LRMCRF 00000079045HL1 417347P500 00000079046HL9 608364PRFPCL 00000079047HL7 218828WDR1 00000079048HL5 269637FP 00000079049HL3 281274P5DGR 00000079457HL8 501202BNLER 00000079460HL2 507434DR1 00000079461HL0 570455GDXR 00000079662HL3 312CMP500D2 00000079663HL1 330841AND 00000080016HL9 724285WDR 00000080196HL9 325574WDRRM1 00000080556HL4 315425A320WDR1 00000080560HL6 301874UBWDR1 00000081032HL5 281477MWBP500D 00000081033HL3 412372DD1 00000081034HL1 608356P500 00000081035HL8 504896R2P500 00000081036HL6 252847EDDIG1 00000081037HL4 252847EDDIG2 00000081038HL2 504873FPR4 00000083548HL8 314919JDR1 00000083876HL3 732840WDROP 00000083877HL1 636239DR2 00000083878HL9 740383WDR1 00000083881HL8 636239MOBDR1 00000084098HL3 404778FPAD 00000084101HL5 0002996020 00000084206HL2 906293DIG2 00000084208HL8 304252FCPROT 00000084209HL6 518292RM4DR 00000084211HL2 781306FP 00000084313HL6 724983500D 00000084314HL4 904271FP1 00000084315HL1 206288WDR1 00000084551HL1 505609FLASH1 00000084552HL9 240566DF1 00000084553HL7 SLWPRO 00000084554HL5 330841PXD 00000084556HL0 330841RFD 00000084989HL3 409212GEDR1 00000085226HL9 828456FLSHPD1 00000085228HL5 732840WDRER1 00000085230HL1 641228WDR1 00000085231HL9 770400WDR1 00000085385HL3 412367WDR 00000085386HL1 815395OSFER1D 00000085387HL9 SLWP500 00000085389HL5 732321WDR3 00000085494HL3 330543WDR1 00000085496HL8 404265FPAD1 00000085604HL7 713SCFP 00000085605HL4 847872WDR1 00000085606HL2 970945ORTHO 00000085607HL0 925370PRO1 00000085609HL6 MH693WDR1 00000085927HL2 713SCFP2 00000086214HL4 731425TR3D 00000086216HL9 731425TR2D 00000086217HL7 636866DR1 00000086219HL3 908522RM8WDR1 00000086463HL7 508FHCMRAD 00000086464HL5 404501P500 00000086465HL2 507537WDR1 00000086466HL0 937OVFLWD 00000086629HL3 636239DR1 00000086631HL9 770968PRO 00000086632HL7 610861WDR1 00000086633HL5 318769ERM1 00000086635HL0 817347FP1 00000086969HL3 817347PRODIG 00000086970HL1 641446WDR1 00000086972HL7 708799PROT 00000087232HL5 404265FPAD2 00000087233HL3 COR481341 00000087379HL4 309344MRF1B 00000087380GK2 410362ER 00000087381HL0 718226PRM10WDR 00000087542HL7 908277WDR1 00000087543HL5 210703FP 00000087545HL0 240566RHRF1 00000087546HL8 706596SFER 00000087657HL3 303269FP1 00000087659HL9 856355P500 00000087660HL7 COR481342 00000087661HL5 651789WDR1 00000087698HL7 602406WD138 00000087701HL9 COMFORTFL3 00000087703HL5 COMFORTFL2 00000088105HL2 718226PRM1WDR 00000088107HL8 0002991687A 00000088108HL6 812934PFP1 00000088110HL2 412647WDR1 00000088396HL7 507434DR3 00000088398HL3 660885WDR1 00000088399HL1 936348MVPRO 00000088400HL7 941355P500D 00000088401HL5 606833P500D 00000089175HL4 760876FP 00000089180HL4 0004034682 00000089181HL2 508996HRAD 00000090002HL7 479587P59 00000090374HL0 507434DR2 00000090375HL7 0004014002A 00000090376HL5 760379FP 00000090626HL3 441236P500 00000090628HL9 865316WDR1 00000090629HL7 205333FL2 00000091206HL3 208422P500D 00000091657HL7 805418XR1 00000091659HL3 479587P52 00000091663HL5 440525PROTEUS 00000091664HL3 360346WDR1 00000091666HL8 479684P500 00000091668HL4 516796DIGDET 00000091878HL9 937208DET 00000091879HL7 505983ORTHPROT 00000091880HL5 719638DP 00000091881HL3 702304RF1DET 00000091882HL1 281450OPT220 00000092402HL7 508833SHRAD 00000092403HL5 281540NECCRF 00000092404HL3 512FCXR200 00000092660HL0 601968WDR2 00000092661HL8 301891P500 00000092662HL6 863314PROT 00000092663HL4 718670CLINIC 00000093036HL2 UICGERF1 00000093038HL8 518292RAD1DR 00000093039HL6 601968ERWDR 00000093040HL4 972899FMPRO 00000093310HL1 318448RF1FP 00000093311HL9 734712AABJ2 00000093312HL7 906341FP1 00000093314HL3 419636RAD 00000093707HL8 918286WDR1 00000093708HL6 512LWMOBRAD 00000093709HL4 732294P5D 00000093710HL2 817865FPSXR220A 00000093711HL0 229312MFP2 00000093712HL8 405744OSUVET 00000093960HL3 760873FP1 00000093961HL1 573686WDR 00000094228HL4 830703VVFP 00000094229HL2 937641RMF 00000094230HL0 818360XR1 00000094374HL6 904215RFWDR 00000094375HL3 330332R4WDR1 00000094747HL3 863314P500 00000094749HL9 207795P500WDR1 00000095000HL6 563589WDR1 00000095001HL4 906341DIG 00000095118HL6 229276FP2 00000095119HL4 719557WDRF1 00000095122HL8 812265WDR1 00000095380HL2 636789PDR 00000095381HL0 740633P500 00000095382HL8 608356P5002WDR1 00000095383HL6 718226VZRM3 00000095387HL7 718670CLINIC 00000095389HL3 573686MOB 00000095390HL1 229276FP1 00000095391HL9 978741SRF3W 00000096330HL6 732530URGW 00000096331HL4 570621WDR1 00000096332HL2 251435I7 00000096333HL0 218741WDR 00000096334HL8 806663RAD 00000096335HL5 601663P500 00000096511HL1 305MCHDORAL 00000096512HL9 314251MR2DR 00000096513HL7 505WHRM1 00000096518HL6 606433PROT 00000096635HL8 304234560 00000096636HL6 502484WDR1FLSH 00000096638HL2 513MWDIG1 00000096993HL1 973726WDR 00000096995HL6 718226VZRM2 00000096996HL4 719557WDRAD 00000098046HL6 717761GDXR 00000098047HL4 229353FP3 00000098051HL6 618664FCRAD 00000098052HL4 229276FP3 00000098053HL2 307672WDR1 00000098056HL5 941629WDR1 00000098057HL3 662751RF2FP 00000098058HL1 808YMP500D 00000098882HL4 513MWDIG2 00000098883HL2 801545FP 00000098884HL0 314251MD1DR 00000098887HL3 DCHRMADIG 00000098888HL1 904202ERDR 00000099152HL1 281420SJM500D1 00000099153HL9 636695MWR1 00000099391HL5 937734PRE 00000099401HL2 309672WDR1B 00000099402HL0 732840WDOP2 00000099403HL8 WDR1ED 00000099404HL6 309672P500D2 00000099405HL3 757889RM4 00000099949HL0 360805PROTEUS 00000099950HL8 815756WDR1 00000099952HL4 518489RF1WDR1 00000099953HL2 570621SEPREC 00000099954HL0 718630FPRM8 00000099955HL7 541276P500DR 000000Y0S11014 WDR1-RF2 000000Y0S11053 405752FP2 000000Y0S11056 660223WDR2 000000Y0S11062 918434P500 000000YOS11041 404686MOTDR1 00000100202HL1 478757DR 00000100203HL9 702255XR2 00000100206HL2 303399P5002 00000100207HL0 330725PROTEUS 00000100209HL6 229391WCFP 00000100211HL2 972566PEDIRF1 00000100385HL4 717761WDR2 00000100387HL0 308865KRDP 00000100388HL8 972841XR220A 00000100389HL6 954355UPGKIT 00000100390HL4 904202ER1DR 00000100714HL5 0004138298 00000100718HL6 281FCDPDM 00000100719HL4 513MWPRE1 00000100720HL2 717733R1B 00000100722HL8 FCLEWPROT 00000101087HL5 757261RM10 00000101089HL1 301877RAD3 00000101137HL8 MH693WDR2 00000101138HL6 310374PRO 00000101661HL7 0004114071 00000101663HL3 940384PRO 00000101669HL0 405372WDR1 00000101670HL8 405372WDR1 00000101671HL6 405949ER1 00000102207HL8 OVERPRO 00000102209HL4 218935WDR1 00000102210HL2 830393CFP 00000102211HL0 863680UCFP 00000102213HL6 415VASFP500 00000102214HL4 419294DR 00000102511HL3 601200FP1 00000102514HL7 304636WDR1 00000102515HL4 513MWPRE2 00000102516HL2 907276P500 00000102518HL8 818563DR 00000102891HL9 412647P500D2 00000102893HL5 412647F3WDR 00000102895HL0 210877PRO 00000102896HL8 281338P500 00000102897HL6 FCMESQXR220 00000102898HL4 0004074932B 00000103168HL1 503399WDR 00000103169HL9 208402RAD1 00000103170HL7 0002922151A 00000103171HL5 703697PROT1DR 00000103174HL9 724588PROTWDR1 00000103175HL6 0004074923B 00000103760HL5 518254WDR3 00000103761HL3 909CH500DFP 00000103763HL9 904321WDR1 00000103767HL0 570523WDRSIC 00000103975HL9 225658RF1 00000103976HL7 518254WDR2 00000103977HL5 0004076901 00000103979HL1 0004076901 00000104296HL9 417347FEP500 00000988882HL4 513MWDIG2 00000Y0S11007A WDR1-RF1 00000090630HL5 XR89403HL0 00000076989HL3 0910072218 00000083546HL2 0910072221 00000093959HL5 0910074035 00000095384HL4 83089910031 00000096515HL2 83098669808 00000096516HL0 83090416600 00000101667HL4 83093535827 00000080557HL2 613969RF1 00000094745HL7 416323RAD2 00000087234HL1 M1797703 00000101659HL1 IE1006WD01 00000085227HL7 A5805631 00000096517HL8 JO1034RX08 00000079664HL9 RO1096XR01 00000081031HL7 RO1096XR01 00000091661HL9 RU1279RX03 00000080195HL1 AE1021RX04 00000077641HL9 00141RAD05 00000080193HL6 10670WDR01 00000084555HL2 00313WDR01 00000084988HL5 00100WDR02 00000089178HL8 00618RAD01 00000094998HL2 00254RAD01 00000095388HL5 05528WDR01 00000101665HL8 IE1564RX03
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM.
  • Description du dispositif
    GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). || The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA