Siemens ARTIS Icono X-Ray Systems Recall
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Siemens Medical Solutions USA, Inc. is recalling ARTIS Icono biplane, ceiling, and floor interventional fluoroscopic x-ray systems due to a software issue that may display an incorrect x-ray dose of 0.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 2026 and geographically references United States and worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
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.
Which Products Are Affected
- ARTIS icono biplane Model 11327600 (UDI 4056869063317)
- ARTIS icono ceiling Model 11328100 (UDI 4056869295923)
- ARTIS icono floor Model 11327700 (UDI 4056869149325)
The recall affects units distributed in the US and worldwide. Recall number: Z-2206-2026. Classification: Class II. Initiated March 9, 2026.
What You Should Do
No specific consumer actions are provided in the recall notice.
Why This Matters
The incorrect dose display may lead to inaccurate records of radiation exposure during procedures.
Source
FDA recall Z-2206-2026 (https://www.fda.gov)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (912 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.