FDA Device recall Z-0523-2024
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of ARTIS icono (ceiling configuration), Fluoroscopic x-ray system by Siemens Medical Solutions Usa, citing potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0523-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-17 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Reason
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
Identifiers
| code_info | UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0523-2024%22
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