ARTIS Icono biplane, floor and ceiling.: ARTIS icono… recallZ-2206-2026 · Siemens Medical Solutions USA, Inc · initiated Mar 9, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.
Recall details
- Recall number
- Z-2206-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 9, 2026
- Posted by the FDA
- Jun 4, 2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product code
- OWB
- FDA submissions
- K241572
- Distribution
- US and Worldwide
Product description
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
Code information (models, lots, serial numbers)
ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
Other devices under the same FDA submission
1 device cleared under K241572 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARTIS pheno 10849000Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system14 recalls64 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98992).
- Z-2205-2026 · Open, ClassifiedARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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