FDA Device recall Z-2311-2018
Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures by Siemens Medical Solutions Usa, citing after the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2311-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-01 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
Reason
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Identifiers
| code_info | 137165 137146 137311 137229 137231 137224 137217 136979 136557 136558 136391 136503 136594 136278 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2311-2018%22
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