Reported Feb 5, 2014 · Terminated
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- Mfg Lot or Serial # System IDUnknown 00000328883HM4 606573O540 00000330505HM9 972596CT540 00000331902HM7 651294OPT 00000333256HM6 Unknown
00000311096HM2561747CT200000317657HM5859313TCCT00000318100HM5765447CDICT00000320796HM6317569CDINE00000322703HM0317846CDINCT00000323060HM4651294OPT00000325273HM1317890CDIS00000325782HM1317890CDIW00000325783HM9INSIGHTCT201300000326335HM7
Unknown 00000342027HM0 620234CT 00000342972HM7 Unknown 00000343769HM6 Unknown00000336763HM8620384CT00000337348HM7850325OPT54000000338324HM7251275GHCTOP54000000338344HM5419ARROWCT00000339268HM5817465PORT00000339269HM3571367OP54000000339708HM0980212CT00000340245HM0704403NCRC00000340698HM0TMCACT54000000341570HM0620257CT54000000341573HM4
Unknown 00000329547HM4 Unknown 00000333910HM8 83094749135 00000336762HM0 83093534693 00000340201HM3 83093282036 00000340648HM5 Unknown 00000344608HM5 Unknown 00000345259HM6 Unknown00000344605HM1419PERRYCT00000300762HM2DZ1061CT0200000308967HM9DZ1460CT0100000310027HM8DZ1466CT0100000310562HM4DZ1070CT0300000311872HM6DZ1481CT0100000311873HM4DZ1255CT0100000313494HM7DZ1476CT0100000318960HM2DZ1551CT0100000326325HM8DZ1482CT0200000326888HM5DZ1404CT0100000332418HM3DZ1526CT0100000304142HM3091021316300000307762HM5091021316400000318131HM0091021223000000320782HM6091021223300000328111HM0091021223300000328289HM4
Unknown 00000339713HM0 Unknown00000304667HM9030079CT0100000326872HM9030173CT0400000314578HM6BG4646CT0100000336118HM5BG4657CT0100000332406HM8416756BSCT00000335739HM9
Unknown 00000327492HM5 Unknown00000308344HM1CI1048CT0200000310563HM2CI1065CT0100000327491HM7CI1070CT0100000313495HM4EG1924CT0100000333231HM9EG1925CT0100000304668HM7X18086970400000304669HM5M604452300000306538HM0M916462100000307761HM7M421603100000310043HM5P420040900000310044HM3M17158701400000310045HM0M111832600000314580HM2M15604820400000315893HM8M447251700000316785HM5X418010100000319320HM8M446530800000319974HM2
Unknown00000330901HM0X2501000600000331618HM9X26833880100000331769HM0M447620600000333921HM5M286281500000334370HM4
Unknown00000335056HM8M419090900000335057HM6B130371100000335740HM7B164860700000335749HM8B239770600000336112HM8X9028160800000336113HM6X75196201400000336740HM6M203513900000336741HM4
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 Unknown00000337349HM5L165021500000337350HM3A603641200000337351HM1M416861200000338321HM3M22607790500000338322HM1F150041900000338323HM9F168083100000339265HM1X75196802300000339266HM9M832290700000339707HM2M18038480900000340244HM3A203211800000340246HM8M15167101500000340247HM6A603971300000340695HM6M601331000000340696HM4M918562800000340697HM2X87401900800000341571HM8M239941000000341572HM6
Unknown00000290194HM0X25509520300000292644HM2782203CT0100000296062HM3695382CT0100000299346HM7PC6686CT0100000303916HM1PC5606CT0100000305394HM9509940CT0100000308345HM8PC4318CT0300000312758HM6826251CT0100000312760HM2PC9940CT0100000314579HM4HC7669CT0300000314581HM0543871CT0200000315066HM1HC0285CT0100000316797HM0387171CT0100000317429HM9387171CT0100000318129HM4409208CT0100000319973HM4409208CT0100000325252HM5
Unknown 00000339274HM3 Unknown 00000339695HM9 Unknown 00000339697HM5 Unknown 00000340645HM1 Unknown 00000341615HM3 Unknown 00000342986HM7 373638CT01 00000342987HM5 Unknown 00000344606HM9 Unknown00000326326HM6HC0953CT0300000327482HM6HC7137CT0200000328740HM6PC7343CT0100000328741HM4PC0252CT0100000329531HM8CC7137CT0200000330485HM4CC1990CT0100000330895HM4HC1172CT0200000332417HM5PC0976CT0100000335099HM8CC1543CT0200000336100HM3
Unknown 00000340646HM9 Unknown00000345260HM4397713CT0100000328882HM600165CTS0400000322028HM208302120003311200000326873HM708302182215001300000330896HM2
Unknown00000332419HM1IQ1365CT0100000290195HM7A527560600000291315HM0A566060600000295316HM4A564960900000302604HM4I527480400000302605HM1A26205460100000306971HM3A512982300000308966HM1B514761200000318130HM2A563600900000318975HM0A512781500000319975HM9A25237560400000320014HM4A594081900000329523HM5A522071600000331768HM2A538982300000339698HM3
Unknown00000345261HM2A527484600000052246YC600000318961HM0KE1045CT0100000315891HM2LV4015CT0100000316786HM3LV4026CT0200000336101HM1LV4058CT0100000325249HM1LB1003CT0300000325251HM7LB1129CT0200000326886HM9LB1068CT0100000320783HM4083421004400000339267HM7MQ1000CT0300000306537HM2MA1385CT0100000306972HM1MA1339CT0200000312759HM4MA1488CT0100000319319HM0MA1093CT0300000329522HM7MA1502CT0100000315067HM9092021905700000325263HM2
Unknown00000325247HM5PK1374CT0100000325248HM3PK1373CT0100000325250HM9PK1372CT0100000313497HM0PL1563CT0100000315892HM0PL2849CT0100000326887HM7PL2935CT0100000328742HM2PL2935CT0100000332407HM6PL2998CT0100000333232HM7PL2257CT0100000335741HM5
Unknown00000339696HM7PL3034CT0100000340647HM7PL1795CT0100000342988HM3PL2855CT0100000340203HM9PPR4520700000302603HM6RO4008CT0300000304758HM6RO1232CT0100000313491HM3RO1234CT0100000313496HM2RO1236CT0100000326327HM4RU8041CT0100000334371HM2RU7808CT0100000340204HM7
Unknown00000049424YC5SA2316CT0100000049477YC3SA2296CT0100000049638YC0SA1014CT0300000049639YC8SA1117CT0100000049640YC6SA2317CT0100000049641YC4SA1099CT0200000049642YC2SA2320CT0100000049643YC0SA2322CT0100000049644YC8SA2319CT0100000049645YC5
Unknown 00000051161YC8 Unknown 00000051253YC3 Unknown 00000051472YC9 Unknown 00000051977YC7 Unknown 00000052281YC3 Unknown 00000052282YC1 Unknown 00000317656HM7 ZA1531CT01 00000327481HM8 Unknown 00000342973HM5 Unknown00000049646YC3SA2323CT0100000049881YC6SA2324CT0100000049882YC4SA1095CT0200000050257YC5SA1345CT0100000050445YC6SA2217CT0100000050719YC4SA2321CT0100000050896YC0SA1264CT0200000050897YC8SA1138CT0200000051160YC0
Unknown 00000300763HM0 Unknown 00000336725HM7 Unknown 00000342041HM1 Unknown 00000345988HM0 Unknown 00000346173HM8 Unknown 00000346174HM6 Unknown 00000346181HM1 Unknown 00000340202HM1 085921011400000300761HM4UEW0451200000310028HM6ME925A1000000310553HM3MP71311700000311090HM5NPV2111100000317430HM7YP31502400000318959HM4NEV0681400000330486HM2UP12361500000333230HM1MP88630300000296063HM1121497CT0100000318099HM9824158CT0100000318128HM6412160CT0100000319322HM4107010CT0400000335109HM5085621016600000313492HM1TN1581CT0100000313493HM9TN1585CT0100000328088HM0TN1087CT0200000334326HM6TN1624CT0100000336739HM8TN1348CT0100000328288HM635060CTS0100000333915HM7
- Mfg Lot or Serial # System ID
- Amount recalled
- 272 (29 US; 243 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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