GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems
Medical device recall Z-0840-2014. Published in FDA’s Enforcement Report on Feb 5, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 5, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 11 states named
- 272 (29 US; 243 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
272 (29 US; 243 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000311096HM2 561747CT2 00000317657HM5 859313TCCT 00000318100HM5 765447CDICT 00000320796HM6 317569CDINE 00000322703HM0 317846CDINCT 00000323060HM4 651294OPT 00000325273HM1 317890CDIS 00000325782HM1 317890CDIW…
Every code shown here, 1,987 characters
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…
FDA’s list runs to 6,828 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- Alabama
- Colorado
- Florida
- Indiana
- Kansas
- Kentucky
- Minnesota
- North Carolina
- Ohio
- Texas
- Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 9, 2013.
- FDA classified it on Jan 27, 2014.
- FDA’s Enforcement Report published it on Feb 5, 2014.
- FDA terminated it on Jun 19, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,828 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.