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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615

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 Class 2 Recall
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615
see related information
Date Posted November 20, 2013
Recall Status1 Terminated on April 01, 2014
Recall Number Z-0367-2014
Recall Event ID 66631
Premarket Notification
510(K) Numbers
K093514  K111445  K113350  K121019 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion). The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used for patients of all ages. The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. - The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scann
Code Information Serial # System ID 21000 262574D670 21023 309671SPECT 21030 856247NM 21032 617638DSV670 21044 404686NMCT 21045 972935D670 21054 262574D630 21062 305674D670 21065 PITT670 21069 212639NMD670 21074 423495D670 21078 615322NM5 21105 803751D670 21111 DUKECCDSV670NM 21114 614NCH670 21117 262574O640 21127 410D6701 21149 540332D670 21157 856247D670 21172 630432D670 21182 GON1409671 21188 415353D670 21189 DUKEDMP670NM 21193 610402D670NM1 21201 720848D670 21202 972747NM670 21221 410955D670 21223 307362D670 21224 660890D670 22002 619474D630 22004 618443DISC1 22007 814623D630 22010 251639D630 22012 704355D630 22013 956523D630 22017 845454D630 22018 618842DISC1 22024 601354D630 22025 773282D630 22026 813558D630 22027 941LWRNM630 22029 PRINCE630 22030 281540D630 22032 417781D630 22033 601288D630 22034 913345D630 22036 318798D630 22039 614NCH630 22040 904321DSC1 22041 317887D630 22042 318448D630 22043 JHDSV630NM 22045 217544PH630 22046 301877D630 22047 601798D630 22048 716372NM630 22049 580531NM630 22050 651DSC630 22052 205333D630 22053 618942NM630 22054 813615D630 22055 719587D630 22056 903GSD630 22057 417533D630 22058 708684D630 22059 937SNHC630 22060 GON1399460 22061 GON1399458 22062 GON1399459 22063 GON2996508 22064 918502DIS1 22065 804675D630A 22066 469814NM630 22067 978354DSV630 22068 585922NM630 22069 305596D630A 22070 GON4029581 22072 POIN630 22076 GON1406902 22077 816234D630 22081 808485NM630 22082 989227D630 22085 305596D630B 22087 801714D630 22088 815564D630 22090 GON1413295 22091 702388VNM2 22092 760778D630 22094 269945D630 22095 843347D630 22096 201418D630 22097 319364D630B 22098 207664NM630 22099 334287NM630 22101 609978D630 22103 843797TD630 22105 319364D630A 22112 OSC630 22117 330386D630 22119 909599D630 22122 904276DSC1 22123 270417D630 22124 901226D630 22125 208455NM630 22126 409212NM630 22127 770751D630 22131 DMP630A 22132 936NMD630 22134 856355D630 22135 DMP630B 22136 605322D630 22137 775STMANM630A 22138 951303D630 22139 850862D630 22141 765447D630 22143 203384D630 22144 WH231NM630 22145 603354NM630 22148 302430NUC630 24001 406222LN615 24003 478272NM 24004 GON1399612 24006 806665NM615 24013 702304NM615 25004 GON1407649 25012 GON1415326 25018 816234D640 25026 928214NMCT 26004 815564O640 26007 817250NM640 26010 717782640NM 26011 GON1415328 26012 808485NM640 26013 847872O640 26014 901516GO640 26018 270956NM640 26020 GON4101170 26021 215728OPT640 26025 410543NUC640 26026 GON1425747 26028 715735OPT1 000000BRI00069 405456NM615 SAN00215 615893MMCT1 00000000107BH3 DZ1060NM01 89315HL6 GON4054688 21002 0910263235 21013 0910263223 21017 0910262297 21020 0910262304 21029 0910263228 21039 0910263231 21041 0910262310 21049 0910263243 21066 0910262319 21075 0910262322 21079 0910267022 21080 0910263239 21081 0910264141 21082 0910262325 21119 0910264135 21140 0910265075 21144 0910265074 21145 0910262344 21147 0910264147 21150 0910263250 26002 0910263256 26005 0910263253 00000000103BH2 0910263259 00000000124BH8 83092327843 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416495D670 21028 082426130029 21052 082426070028 21076 082426080020 21083 082426040043 21092 082426070030 21101 082426130030 21113 082426040044 21118 082426090029 21131 082426150026 21138 082426090030 21165 GON2992427 21166 82426070031 21183 082426160042 21207 082426230020 21212 GON4061530 21213 82426040052 21222 82426040053 21231 GON4103085 SAN00186 082426210020 22116 NM22116 24015 NM24015 22102 NM22102 22129 GON4070458 21019 DK1029NU14 21055 DK1047NM01 26009 DK1054NM03 83BH6 EG1040NM01 21154 EE1020NM03 21009 FI1052MN01 21021 M4210246 21022 X102874005 21033 M4134637 21035 M9409545 21037 M4198090 21063 M4505290 21064 M5172553 21067 M9886847 21070 M2002713 21073 X4144501 21086 M4143630 21095 M4476424 21121 M5480777 21128 M251400603 21134 A4194844 21141 A4169312 21146 M4145158 21152 V4144610 21153 M5400562 21159 M4215577 21186 M4194042 21187 M4144126 21197 V4169306 21206 M4143993 21216 B4182011 21220 GON4094739 22014 M4216453 22016 M4476428 22079 V6414107 22084 M45052111 22121 M2148252 26001 XM203401 21024 UX2305NU01 21196 PC8262NU01 21226 TP0007NU02 22001 TP0004NU01 22011 PMAB01NU04 22023 PC3003NU01 22078 407431NU01 22089 HC0863NU02 22108 870939NU02 22109 870939NU01 22115 600791NU01 22140 HG4437NU04 24002 HC0541NU03 24009 387171NU01 24010 HC3366NU02 25027 GON4072189 26003 ULUE01NU02 26015 915839NU01 22107 H3001NUC01 21093 GP1000NM01 21158 082426060005 21168 GON4034976 21170 0828260021 21199 0828260022 21230 GON4093290 21004 083026201006810 21014 083026009408410 21053 083026023683711 22005 083026001113611 22133 GON4077924 24007 083026241010212 26024 083026800008113 21155 IE1018MN03 22021 IE1044NM01 21031 IL1041NM30 21129 IL1062NM29 00ME1 IL1020NM36 21012 A5129983 21059 A51142126 21151 B5140618 21163 A51051127 21185 A5125139 21205 A5196344 22022 A5384208 22031 A5812287 22035 A5131865 22086 A5366307 24008 A5635609 26006 A5639613 26008 A5366308 21089 NT1001 21097 NT1002 21100 NT2001 21136 NT1006 22044 NT1008 22071 NT3010 22104 NT3002 22110 NT3003 22111 GON4076657 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21180 RU1279NM02 21190 GON4057943 21195 GON4061978 22083 RU1136NM01 00000290644HM4 RU1493NM01 00000093077HL6 SA1034NM01 00000321622HM3 SA2281NM01 00000322039HM9 SA1006NM01 95718HL3 GON4035845 21219 0847260029 22106 ZA2487NM01 24005 ZA2446NM01 24012 ZA1819NM04 21007 MEX68915 21047 FE416061 21175 D007NU12 21203 M001NU42 21217 O005NU27 21218 M001NU43 22075 H002NU03 22113 O009NU09 26023 BD003NU01 21005 529150NU05 21072 900010NU09 21177 475260NU01 21191 260010NU06 21099 0853260094 21171 0853260099 21096 0856260034 21107 0856260033 21169 0856260035 21091 06007NUC19 22128 34363NUC01 21003 00200NUC07 21006 00200NUC08 21010 00361NUC08 21027 00046NUC06 21036 00042NUC02 21043 10497NUC20 21046 00065NUC08 21051 00028NUC01 21084 00001NUC12 21108 00197NUC14 21116 00199NUC13 21120 11018NUC08 21124 00432NUC02 21133 00123NUC01 21176 00234NUC09 21181 05462NUC05 21192 00271NUC07 21208 00149NUC03 21225 00310NUC06 21227 00149NUC01 22015 00001NUC11 22028 00052NUC11 22100 00271NUC10 25021 GON4074530 26017 00162NUC11 26019 00203NUC06 26022 00139NUC08 FMI40851DUM002 00133NUC36 FMI40851DUM003 00242NUC06 SAN00200 00258NUC02
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 related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a
FDA Determined
Cause 2
TRAINING: Employee Error
Action GE Healthcare sent an "Urgent Medical Device Correction" letter dated September 25, 2013, to all affected customers. The letter identified the product the problem and the actions to be taken by the customer. We plan to correct all of the affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 systems that were distributed The plan for public warning is to contact all customers with an affected Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615 system by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to 3 titles within the affected accounts; Managers of Nuclear Medicine, Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology. A GE Healthcare Field Engineer will perform the required software update on each affected system. Contact Information (GE Healthcare Call Center: USA or Canada 800-437-1171 and Other countries:( 262-896-2890).
Quantity in Commerce 464 (143 US, 321 OUS)
Distribution Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MI, ME, MD, MA, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WV and WI., and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY,. JAPAN, REPUBLIC OF KOREA, KUWAIT, MEXICO, NETHERLANDS, NEW ZEAL NAD, NORWAY, PAKISTAN, POLAND,QUATAR, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN,K THAILAND, TURKEY and 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 HEALTHCARE
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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