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U.S. Department of Health and Human Services

Class 2 Device Recall GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems

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 Class 2 Recall
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems
see related information
Date Posted January 27, 2014
Recall Status1 Terminated on June 19, 2014
Recall Number Z-0840-2014
Recall Event ID 66917
Premarket Notification
510(K) Numbers
K082816  K123596 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information Mfg Lot or Serial # System ID 00000311096HM2 561747CT2 00000317657HM5 859313TCCT 00000318100HM5 765447CDICT 00000320796HM6 317569CDINE 00000322703HM0 317846CDINCT 00000323060HM4 651294OPT 00000325273HM1 317890CDIS 00000325782HM1 317890CDIW 00000325783HM9 INSIGHTCT2013 00000326335HM7 Unknown 00000328883HM4 606573O540 00000330505HM9 972596CT540 00000331902HM7 651294OPT 00000333256HM6 Unknown 00000336763HM8 620384CT 00000337348HM7 850325OPT540 00000338324HM7 251275GHCTOP540 00000338344HM5 419ARROWCT 00000339268HM5 817465PORT 00000339269HM3 571367OP540 00000339708HM0 980212CT 00000340245HM0 704403NCRC 00000340698HM0 TMCACT540 00000341570HM0 620257CT540 00000341573HM4 Unknown 00000342027HM0 620234CT 00000342972HM7 Unknown 00000343769HM6 Unknown 00000344605HM1 419PERRYCT 00000300762HM2 DZ1061CT02 00000308967HM9 DZ1460CT01 00000310027HM8 DZ1466CT01 00000310562HM4 DZ1070CT03 00000311872HM6 DZ1481CT01 00000311873HM4 DZ1255CT01 00000313494HM7 DZ1476CT01 00000318960HM2 DZ1551CT01 00000326325HM8 DZ1482CT02 00000326888HM5 DZ1404CT01 00000332418HM3 DZ1526CT01 00000304142HM3 0910213163 00000307762HM5 0910213164 00000318131HM0 0910212230 00000320782HM6 0910212233 00000328111HM0 0910212233 00000328289HM4 Unknown 00000329547HM4 Unknown 00000333910HM8 83094749135 00000336762HM0 83093534693 00000340201HM3 83093282036 00000340648HM5 Unknown 00000344608HM5 Unknown 00000345259HM6 Unknown 00000304667HM9 030079CT01 00000326872HM9 030173CT04 00000314578HM6 BG4646CT01 00000336118HM5 BG4657CT01 00000332406HM8 416756BSCT 00000335739HM9 Unknown 00000339713HM0 Unknown 00000308344HM1 CI1048CT02 00000310563HM2 CI1065CT01 00000327491HM7 CI1070CT01 00000313495HM4 EG1924CT01 00000333231HM9 EG1925CT01 00000304668HM7 X180869704 00000304669HM5 M6044523 00000306538HM0 M9164621 00000307761HM7 M4216031 00000310043HM5 P4200409 00000310044HM3 M171587014 00000310045HM0 M1118326 00000314580HM2 M156048204 00000315893HM8 M4472517 00000316785HM5 X4180101 00000319320HM8 M4465308 00000319974HM2 Unknown 00000327492HM5 Unknown 00000330901HM0 X25010006 00000331618HM9 X268338801 00000331769HM0 M4476206 00000333921HM5 M2862815 00000334370HM4 Unknown 00000335056HM8 M4190909 00000335057HM6 B1303711 00000335740HM7 B1648607 00000335749HM8 B2397706 00000336112HM8 X90281608 00000336113HM6 X751962014 00000336740HM6 M2035139 00000336741HM4 Unknown 00000337349HM5 L1650215 00000337350HM3 A6036412 00000337351HM1 M4168612 00000338321HM3 M226077905 00000338322HM1 F1500419 00000338323HM9 F1680831 00000339265HM1 X751968023 00000339266HM9 M8322907 00000339707HM2 M180384809 00000340244HM3 A2032118 00000340246HM8 M151671015 00000340247HM6 A6039713 00000340695HM6 M6013310 00000340696HM4 M9185628 00000340697HM2 X874019008 00000341571HM8 M2399410 00000341572HM6 Unknown 00000341614HM6 Unknown 00000342028HM8 Unknown 00000342042HM9 M2311408 00000342043HM7 M4166654 00000342970HM1 M4202009 00000342971HM9 Unknown 00000343741HM5 Unknown 00000343742HM3 Unknown 00000343767HM0 Unknown 00000343768HM8 Unknown 00000344607HM7 Unknown 00000344616HM8 Unknown 00000345262HM0 Unknown 00000290194HM0 X255095203 00000292644HM2 782203CT01 00000296062HM3 695382CT01 00000299346HM7 PC6686CT01 00000303916HM1 PC5606CT01 00000305394HM9 509940CT01 00000308345HM8 PC4318CT03 00000312758HM6 826251CT01 00000312760HM2 PC9940CT01 00000314579HM4 HC7669CT03 00000314581HM0 543871CT02 00000315066HM1 HC0285CT01 00000316797HM0 387171CT01 00000317429HM9 387171CT01 00000318129HM4 409208CT01 00000319973HM4 409208CT01 00000325252HM5 Unknown 00000326326HM6 HC0953CT03 00000327482HM6 HC7137CT02 00000328740HM6 PC7343CT01 00000328741HM4 PC0252CT01 00000329531HM8 CC7137CT02 00000330485HM4 CC1990CT01 00000330895HM4 HC1172CT02 00000332417HM5 PC0976CT01 00000335099HM8 CC1543CT02 00000336100HM3 Unknown 00000339274HM3 Unknown 00000339695HM9 Unknown 00000339697HM5 Unknown 00000340645HM1 Unknown 00000341615HM3 Unknown 00000342986HM7 373638CT01 00000342987HM5 Unknown 00000344606HM9 Unknown 00000345260HM4 397713CT01 00000328882HM6 00165CTS04 00000322028HM2 083021200033112 00000326873HM7 083021822150013 00000330896HM2 Unknown 00000340646HM9 Unknown 00000332419HM1 IQ1365CT01 00000290195HM7 A5275606 00000291315HM0 A5660606 00000295316HM4 A5649609 00000302604HM4 I5274804 00000302605HM1 A262054601 00000306971HM3 A5129823 00000308966HM1 B5147612 00000318130HM2 A5636009 00000318975HM0 A5127815 00000319975HM9 A252375604 00000320014HM4 A5940819 00000329523HM5 A5220716 00000331768HM2 A5389823 00000339698HM3 Unknown 00000345261HM2 A5274846 00000052246YC6 00000318961HM0 KE1045CT01 00000315891HM2 LV4015CT01 00000316786HM3 LV4026CT02 00000336101HM1 LV4058CT01 00000325249HM1 LB1003CT03 00000325251HM7 LB1129CT02 00000326886HM9 LB1068CT01 00000320783HM4 0834210044 00000339267HM7 MQ1000CT03 00000306537HM2 MA1385CT01 00000306972HM1 MA1339CT02 00000312759HM4 MA1488CT01 00000319319HM0 MA1093CT03 00000329522HM7 MA1502CT01 00000315067HM9 0920219057 00000325263HM2 Unknown 00000325247HM5 PK1374CT01 00000325248HM3 PK1373CT01 00000325250HM9 PK1372CT01 00000313497HM0 PL1563CT01 00000315892HM0 PL2849CT01 00000326887HM7 PL2935CT01 00000328742HM2 PL2935CT01 00000332407HM6 PL2998CT01 00000333232HM7 PL2257CT01 00000335741HM5 Unknown 00000339696HM7 PL3034CT01 00000340647HM7 PL1795CT01 00000342988HM3 PL2855CT01 00000340203HM9 PPR45207 00000302603HM6 RO4008CT03 00000304758HM6 RO1232CT01 00000313491HM3 RO1234CT01 00000313496HM2 RO1236CT01 00000326327HM4 RU8041CT01 00000334371HM2 RU7808CT01 00000340204HM7 Unknown 00000049424YC5 SA2316CT01 00000049477YC3 SA2296CT01 00000049638YC0 SA1014CT03 00000049639YC8 SA1117CT01 00000049640YC6 SA2317CT01 00000049641YC4 SA1099CT02 00000049642YC2 SA2320CT01 00000049643YC0 SA2322CT01 00000049644YC8 SA2319CT01 00000049645YC5 Unknown 00000049646YC3 SA2323CT01 00000049881YC6 SA2324CT01 00000049882YC4 SA1095CT02 00000050257YC5 SA1345CT01 00000050445YC6 SA2217CT01 00000050719YC4 SA2321CT01 00000050896YC0 SA1264CT02 00000050897YC8 SA1138CT02 00000051160YC0 Unknown 00000051161YC8 Unknown 00000051253YC3 Unknown 00000051472YC9 Unknown 00000051977YC7 Unknown 00000052281YC3 Unknown 00000052282YC1 Unknown 00000317656HM7 ZA1531CT01 00000327481HM8 Unknown 00000342973HM5 Unknown 00000300761HM4 UEW04512 00000310028HM6 ME925A10 00000310553HM3 MP713117 00000311090HM5 NPV21111 00000317430HM7 YP315024 00000318959HM4 NEV06814 00000330486HM2 UP123615 00000333230HM1 MP886303 00000296063HM1 121497CT01 00000318099HM9 824158CT01 00000318128HM6 412160CT01 00000319322HM4 107010CT04 00000335109HM5 0856210166 00000313492HM1 TN1581CT01 00000313493HM9 TN1585CT01 00000328088HM0 TN1087CT02 00000334326HM6 TN1624CT01 00000336739HM8 TN1348CT01 00000328288HM6 35060CTS01 00000333915HM7 Unknown 00000300763HM0 Unknown 00000336725HM7 Unknown 00000342041HM1 Unknown 00000345988HM0 Unknown 00000346173HM8 Unknown 00000346174HM6 Unknown 00000346181HM1 Unknown 00000340202HM1 0859210114
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional Information Contact Call Center
800-437-1171
Manufacturer Reason
for Recall
There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent on 10/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated October 9, 2013. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare Service Representative or the GE Healthcare Call Center : US or Canada : 800-437-1171 and Other countries: 262-896-2890).
Quantity in Commerce 272 (29 US; 243 OUS)
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.
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 = JAK and Original Applicant = GE HANGWEI MEDICAL SYSTEMS CO., LTD.
510(K)s with Product Code = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
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