FDA Device recall Z-0776-2019
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
- FDA Device
- Class II
- ongoing
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography… by Ge Healthcare, citing on the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0776-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-12 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Reason
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator
Identifiers
| code_info | SmartStep Option |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0776-2019%22
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