FDA Device recall Z-2206-2026
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600 by Siemens Medical Solutions Usa, citing during patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2206-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-09 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Reason
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Identifiers
| code_info | ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2206-2026%22
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