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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690.

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 Class 2 Recall
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690.
see related information
Date Posted February 14, 2014
Recall Status1 Terminated on July 29, 2014
Recall Number Z-0981-2014
Recall Event ID 67343
Premarket Notification
510(K) Number
K081496 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
Code Information FMI 13715 Serial # System ID 00000012391PT9 530UCVETPET 00000012525PT2 RHCDISC710 00000012544PT3 856247PETUPS 00000012561PT7 505216D710 00000012574PT0 858805PCT 00000012615PT1 630432D710 00000012674PT8 801581D710 00000012723PT3 602839D710 00000012732PT4 402327D610 00000012752PT2 719365PETCT 00000012771PT2 414805D710 00000012834PT8 904710PET 00000012843PT9 918505PETCT1 00000012849PT6 205975PET1 00000012865PT2 205975PET2 00000012896PT7 985542D610 00000012915PT5 256386HKPETCT 00000012924PT7 318675D710 00000012937PT9 504842D600 00000012961PT9 303673PETCT 00000012975PT9 605328D710 00000013017PT9 608WIMRD710 00000013057PT5 847872D610 00000013066PT6 4056793 00000013067PT4 212288DST710 00000013072PT4 002902086 00000013081PT5 253968D710 00000013101PT1 270688PETCT 00000012473PT5 910452029 00000012749PT8 910456003 00000012837PT1 83095572097 00000012888PT4 83092720723 00000013026PT0 83092879582 00000012626PT8 AH0132PE01 00000012774PT6 306655D710 00000012533PT6 CT428868CN4 00000012900PT7 EGL067 00000012538PT5 HC1992PE01 00000012582PT3 DK1043PT02 00000012819PT9 DK1054PT17 00000012963PT5 EG1017PT01 00000012993PT2 EG1525PT01 00000012822PT3 A4166968 00000012970PT0 M9886853 00000013082PT3 M4145026 00000013099PT7 EGL110 00000012717PT5 8.30458E+13 00000012722PT5 8.3045E+13 00000012738PT1 8.3045E+13 00000012871PT0 4065738 00000012881PT9 4108707 00000012909PT8 83045062157413 00000012921PT3 8.30452E+13 00000013020PT3 8.30452E+13 00000013127PT6 4119154 00000012600PT3 A5124541 00000012638PT3 A5367810 00000012644PT1 A5366305 00000012655PT7 B5801736 00000012756PT3 A51142135 00000012877PT7 A51051131 00000012887PT6 A51273167 00000012930PT4 A5330720 , A5330718 , A5330719 00000012940PT3 B5315353 00000013023PT7 B5811440 00000012553PT4 GQF002 00000012568PT2 SQF701 00000012585PT6 GQF001 00000012649PT0 SQF001 00000012735PT7 GQF003 00000012766PT2 GQF004 00000012807PT4 SQF710 00000012811PT6 GQ0001 00000012951PT0 SQF003 00000013048PT4 EGL098 00000013078PT1 EGL106 00000013112PT8 EGL116 00000013118PT5 EGL117 00000012599PT7 850450166 00000012665PT6 850450167 00000012788PT6 850450169 00000012801PT7 PL1674PT01 00000012996PT5 PL3057PT01 00000013008PT8 PL2711PT01 00000013038PT5 PL3040PT01 00000013075PT7 EGL105 00000013054PT2 RO1252PT01 00000013014PT6 PET13014PT6 00000012589PT8 34339PET01 00000012868PT6 34367PET01 00000012913PT2 00060DST05 00000012925PT4 00060DST04 00000012931PT2 00060CTS02 00000013007PT0 00040DST01 FMI 13716 Serial # System ID 00000001240PT5 262574DST3 00000011146PT8 717657CTPT 00000011218PT5 631MSKPCTD600 00000011233PT4 845695PCT600 00000011344PT9 718370DST6 00000011428PT0 386586FHD600 00000011472PT8 928788PETCT 00000011491PT8 405271PET2 00000011531PT1 386943FHDD600 00000011556PT8 262434D600 00000011565PT9 417347PET 00000011603PT8 479936PETHOG 00000011628PT5 813745D600 00000011636PT8 937771PCT 00000011650PT9 562826D600 00000011653PT3 201858PT600 00000011713PT5 425952D600 00000011714PT3 813396D600 00000011807PT5 626AHMC560 00000011815PT8 520AZO560 00000011870PT3 626COH560 00000011877PT8 RADNETPT1826 00000011912PT3 805739PET1 00000011919PT8 219879PET 00000011923PT0 201858PT2 00000011934PT7 704225PET 00000011937PT0 256308PET 00000011938PT8 RADNETPT619 00000011939PT6 985649D600 00000012244PT0 510537PET 00000012440PT4 770400PCT 00000010847PT2 520UMID690 00000011014PT8 515643D690 00000011240PT9 214370D690 00000011243PT3 312996D690 00000011297PT9 212639PETD690 00000011339PT9 713563D690 00000011435PT5 3154PCT690 00000011460PT3 309672PCT 00000011463PT7 951704PTCT 00000011508PT9 212639PET2D690 00000011553PT5 901595D690 00000011570PT9 480256D690 00000011655PT8 609730D690 00000011757PT2 215464PETCT 00000011851PT3 LARKIND690 00000011878PT6 404712PCT 00000011885PT1 570824PCT690VCT 00000012087PT3 201222PET690 00000012117PT8 312440VCT690 00000012190PT5 916UCDPETCT2 00000012205PT1 681342PCT690 00000012227PT5 716859690VCT 00000012254PT9 614NCH690 00000012257PT2 570476PCT690E 00000012382PT8 970945PET 00000012413PT1 713SCD690 00000012495PT8 804VCUPET690 00000012897PT5 518626PCT 00000010622PT9 650724PET60 00000010952PT0 310888D600 00000010058PT6 NM178700 00000010546PT0 MSK68PET690 00000010816PT7 717242D690PET 00000010902PT5 262928D690 00000011071PT8 816234PETCT 00000011082PT5 574364PET 00000011905PT7 504883D690 00000010454PT7 Shipped 00000010964PT5 Shipped 00000011377PT9 Shipped 00000011427PT2 Shipped 00000013032PT8 Shipped 00000011735PT8 910452027 00000012456PT0 910454013 00000010110PT5 910454012 00000010571PT8 AH5689PE02 00000011227PT6 270617PT02 00000011429PT8 030359PT03 00000011932PT1 BA4073PT01 00000011325PT8 PT256897HM0 00000011497PT5 PET265111HM5 00000011511PT3 PET266034HM8 00000011523PT8 1365454 00000011634PT3 PET269197HM0 00000011728PT3 PET11728PT3 00000011743PT2 2831318PT 00000011783PT8 PET11783PT8 00000011822PT4 PETSXPT0004 00000011846PT3 PET11846PT3 00000011855PT4 CTSXPT00002 00000011911PT5 PETSXPT00001 00000012247PT3 PET12247PT3 00000012642PT5 PET12642PT5 00000012189PT7 PET12189PT7 00000011027PT0 2834425 00000011587PT3 PETSXPT00005 00000011872PT9 PET274985HM1 00000012009PT7 PET12009PT1 00000012448PT7 PET12447PT9 00000012489PT1 PET12489PT1 00000012817PT3 Shipped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hipped 00000011744PT0 X256517201 00000011902PT4 V7405216 00000012174PT9 M256517201 00000012182PT2 X257514801 00000011350PT6 X6010802 00000011356PT3 M1631413 00000011371PT2 B4155424 00000011494PT2 B1768006 00000011516PT2 M5173626 00000011551PT9 M4505295 00000011602PT0 M7417003 00000011627PT7 M4160468 00000011750PT7 A4166958 00000011754PT9 A2943401 00000011888PT5 X4211008 00000012176PT4 M251400604 00000012304PT2 M54606120 00000012347PT1 M4135181 00000012352PT1 M171582005 00000010046PT1 M40180107 00000010648PT4 M4143978 00000011021PT3 M227138301 00000011741PT6 RU1195PT02 00000011829PT9 RU1195PT01 00000011935PT4 NG1127PT01 00000012659PT9 RU2527PT02 00000012777PT9 QA1064PT01 00000012364PT6 GE1004PT01 00000010985PT0 HC0881PE01 00000011190PT6 125521PE01 00000011199PT7 HLAH01PE01 00000012206PT9 HC7946PE02 00000010955PT3 HC0881PE01 00000012342PT2 828450017 00000011808PT3 83045803345211 00000012331PT5 83045202930312 00000011770PT5 83045826760711 00000012689PT6 83045822047612 00000011092PT4 Shipped 00000011388PT6 83045861981111 00000011462PT9 83045002714311 00000011809PT1 83045241979711 00000011901PT6 83045840038411 00000011933PT9 83045842087012 00000012698PT7 83045029088212 00000012704PT3 83045200514712 00000011244PT1 IR1081PT02 00000010509PT8 IL1020NM35 00000011612PT9 A5402105 00000012340PT6 A51272119 00000010846PT4 A5129989 00000011136PT9 F5119164 00000011196PT3 A51043178 00000011534PT5 A5292313 00000011774PT7 A5107783 00000012212PT7 A5691213 00000012255PT6 A5639606 00000010198PT0 B5140608 00000010616PT1 A5216840 00000011147PT6 MF0305 00000011181PT5 MF0303 00000011191PT4 MF0301 00000011219PT3 MFV304 00000011329PT0 MF0313 00000011345PT6 MF0304 00000011418PT1 MF0338 00000011528PT7 MFV305 00000011641PT8 MFV310 00000011796PT0 MF0101 00000011847PT1 MFV306 00000011976PT8 MF0306 00000012118PT6 MFV307 00000012188PT9 MF0016 00000012245PT7 MF0400 00000012348PT9 MFV308 00000012373PT7 MF0012 00000012471PT9 MFV351 00000011379PT5 FT0051 00000011661PT6 FTV621 00000012184PT8 FTV002 00000012386PT9 FTV051 00000012396PT8 FTV003 00000012398PT4 FTV004 00000012405PT7 FTV005 00000010799PT5 FT0101 00000011871PT1 JO1139PT01 00000011179PT9 850450127 00000011387PT8 850450136 00000011814PT1 850450157 00000011936PT2 850450160 00000012202PT8 850450170 00000011228PT4 850450130 00000011268PT0 850450129 00000011571PT7 850450146 00000011662PT4 850450137 00000011931PT3 850450155 00000012057PT6 850450161 00000012146PT7 850450154 00000012357PT0 850450162 00000012197PT0 000850450163 00000012236PT6 KW1020PT01 00000011977PT6 LB1331PT01 00000012374PT5 834450015 00000011991PT7 PET11991PT7 00000011992PT5 CT11992PT5 00000012466PT9 PET12466PT9 00000012720PT9 CT12720PT9 00000011224PT3 2901300DISC 00000012857PT9 PET12857PT9 00000012015PT4 PET12015PT4_ 00000012339PT8 MA1135PT01 00000011260PT7 920459004 00000011319PT1 920459004 00000011355PT5 920459005 00000010603PT9 920459002 00000011011PT4 NO1260PE01 00000010848PT0 PL1791PT01 00000011186PT4 PL1803PT01 00000012256PT4 PL1541PT01 00000011731PT7 RU2527PT01 00000011581PT6 RU1712PT01 00000011606PT1 RU1712PT02 00000012564PT1 RU8370RP01 00000012985PT8 PET12985PT8 00000011622PT8 SA2253PT01 00000011881PT0 SA1054PT01 00000012266PT3 SA1013PT01 00000010962PT9 SA1058PT01 00000011773PT9 MPX29917 00000012081PT6 FPG12206 00000011420PT7 M001PE06 00000010990PT0 120810PE01 00000011554PT3 529150PE03 00000011632PT7 260010PE01 00000012066PT7 547090PE01 00000011385PT2 0853450112 00000012514PT6 853450121 00000012511PT2 856450003 00000012632PT6 856450005 00000011727PT5 TN1010PT01 00000011642PT6 34372PET01 00000011668PT1 23011PET01 00000011975PT0 58012PET01 00000011398PT5 34329PET01 00000011611PT1 41023PET01 00000011880PT2 34344PET01 00000012290PT3 Shipped 00000012335PT6 Shipped 00000011436PT3 00860DST02 00000012054PT3 IE1510MN19 00000010083PT4 70001DST02 00000010220PT2 70065DST01 00000010715PT1 00139DST01
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600, 610, 710 and Discovery 690.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Software Manufacturing/Software Deployment
Action GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2013, and December 4, 2013, to all affected consignees. The letters described the Safety Issue, Safety Instructions, Affected Products Details, Product Correction and Contact Information ( In the US Call 1-800-437-1171. For other countries contact your local GE Healthcare Service Representative). Customers were given the following instructions: To avoid potential issues, replay the list mode data prior to another acquisition. In the event another acquisition is made before replaying the list data, or following reboot, do the following steps: ® Perform a PET only acquisition using the same tracer that is intended for the List Mode Replay. ® Then, proceed to perform the List Mode Replay and subsequent reconstructions. ® Make sure to perform a quality check on any images created after any replay of data. Affected Product Details PET Discovery 610 and PET Discovery 710, with software versions pet_coreload.44 and pet_mfk.44. The software version is visible on the homepage of the service desktop. To determine the software version currently on your system, do the following: 1. On the right monitor upper left corner select the Service Icon. 2. Verify that the Service window is under Home. 3. Locate the SW Build Version listed in the center of the page. For questions regarding this recall call 800-437-1171.
Quantity in Commerce 376 (101 US, 275 OUS)
Distribution Worldwide Distribution - USA including AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KY, LA, MN, MO, NE, NJ, NM, NY, NC, OH, OK, PA, SD, TN, TX, UT, VA, WA, WV, WI and Internationally to: AUSTRALIA, AUSTRIA BELGIUM BOSNIA AND HERZEGOVINA, BRAZIL, CANADA, CHILE, COLOMBIA, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, FINLAND, GEORGIA, GERMANY, HONG KONG, IRAN, ISRAEL INDIA,M ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEW ZEALAND, NORWAY, RUSSIA, REPUBLIC OF KOREA, POLAND, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TUNISIA, THAILAND, TURKEY, UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS, LLC
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