FDA Device recall Z-0840-2014
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems by Ge Healthcare, citing 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'….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0840-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-09 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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.
Reason
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
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000311096HM2 561747CT2 00000317657HM5 859313TCCT 00000318100HM5 765447CDICT 0000032…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 00000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0840-2014%22
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