FDA Device recall Z-2643-2026
ARTIS icono floor
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of ARTIS icono floor by Siemens Medical Solutions Usa, citing potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2643-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-20 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ARTIS icono floor. Model Number: 11327700.
Reason
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Identifiers
| code_info | Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083,…Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Siemens Medical Solutions Usa
- ARTIS icono biplane
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - ARTIS icono ceiling
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - ARTIS icono ceiling
FDA Device · Class II · 2026-07-08 · Siemens Medical Solutions Usa - ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
FDA Device · Class II · 2026-06-10 · Siemens Medical Solutions Usa - ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600
FDA Device · Class II · 2026-06-10 · Siemens Medical Solutions Usa
All Siemens Medical Solutions Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2643-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.