Siemens ARTIS pheno Recall Issued by FDA
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Siemens Medical Solutions USA, Inc. is recalling the ARTIS pheno interventional fluoroscopic x-ray system (Model 10849000) after the device may display an incorrect x-ray dose of zero.
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 ARTIS pheno 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 pheno, Model 10849000, interventional fluoroscopic x-ray system. UDI: 4056869046877. Distributed in the US and Worldwide. Recall number Z-2205-2026. Initiated March 9, 2026. Classification: Class II.
What You Should Do
Consumers and facilities should follow instructions provided by Siemens Medical Solutions USA, Inc. or contact the firm for further guidance on the affected systems.
Why This Matters
The recall addresses a display malfunction in an interventional fluoroscopic x-ray system used during patient examinations.
Source
FDA recall number Z-2205-2026, event ID 98992. Recalling firm: Siemens Medical Solutions USA, Inc., Malvern, PA.
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 (1,014 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.