FDAFDA · Food and drugs·Recall number Z-1078-2014
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.
Published March 5, 2014 · Recall initiated: January 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- 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.
- Lot
- 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 00000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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