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 | Ongoing |
| Reason | When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition. |
| Product | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patie… |
| Distribution | US |
| Initiated | 2021-06-30 |
| Classified | 2021-07-08 |
| Recall number | Z-2022-2021 |
| Initiation | FDA Mandated |
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-2022-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88208/
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