Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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. |
| Quantity | 244 |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT, FL, GA, HI, IL, IN, IA, KY,ME, MD,MA, MI,MN, MS, NV, NH, NJ, NY, NC, PA, TN, TX, VA, WA,WV, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANDA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, NEW ZEALAND, POL… |
| Initiated | 2011-04-05 |
| Classified | 2013-08-09 |
| Terminated | 2014-08-11 |
| Recall number | Z-1940-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-1940-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65333/
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