FDA Device recall Z-1940-2013
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the bod…
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the bod… by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1940-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-04-05 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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
Identifiers
| code_info | GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3…GSI Viewer on CT750HD CT Systems Software Update to 10MW25.6 Serial# 00000409809CN1 00000421170CN2 00000409525CN3 00000410002CN0 00000408483CN6 00000406075CN2 00000404225CN5 00000405725CN3 00000408128CN7 00000409481CN9 00000408280CN6 00000419816CN4 00000408127CN9 00000408230CN1 00000409450CN4 00000412501CN9 00000411125CN8 00000409344CN9 00000409145CN0 00000412398CN0 00000409881CN0 00000413835CN0 00000413765CN9 00000411126CN6 00000412015CN0 00000412399CN8 00000411349CN4 00000411611CN7 00000414853CN2 00000415105CN6 00000416839CN9 00000416410CN9 00000409806CN7 00000414686CN6 00000420612CN4 00000421374CN0 00000411613CN3 00000415502CN4 00000412042CN4 00000414971CN2 00000413841CN8 00000413362CN5 00000413566CN1 00000420173CN7 00000412503CN5 00000415396CN1 00000415826CN7 00000421147CN0 00000414851CN6 00000415104CN9 00000419891CN7 00000420174CN5 00000414852CN4 00000414973CN8 00000416765CN6 00000418112CN9 00000418335CN6 00000420610CN8 |
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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-1940-2013%22
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