GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography… — Class II medical device recall Z-1940-2013
Terminated recall by GE Healthcare, LLC, reported 2013-08-21, distributed nationwide. GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was
| Recall number | Z-1940-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-04-05 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CH, CN, DE, DK, FI, FR, GB, GR, HK, ID, IE, IL, IN, IT, JO, JP, KR, KW, LV, NZ, PL, SA, SE, SG, ZA |
| Quantity | 244 |
| Reason classes | software |
| Serial numbers | 00000404225CN5, 00000405725CN3, 00000405726CN1, 00000406075CN2, 00000407781CN4, 00000407937CN2, 00000408127CN9, 00000408128CN7, 00000408230CN1, 00000408280CN6, 00000408320CN0, 00000408437CN2, 00000408483CN6, 00000408673CN2, 00000409145CN0, 00000409159CN1, 00000409160CN9, 00000409343CN1, 00000409344CN9, 00000409408CN2, 00000409450CN4, 00000409451CN2, 00000409481CN9, 00000409525CN3, 00000409575CN8 and 219 more |
Product
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages.
Reason for recall
GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1 - There was a report regarding CT number variance in time line at posterior fossa region of head perfusion. When beam hardening and helical artifacts in this region are reconstructed into the perfusion map, these artifacts will give subtle differences in the CT numbers. Event 2 - The software does no
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1940-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.