Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Siemens Medical Solutions USA, Inc recalled 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. FDA's record states the reason for recall as: 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.. The recall.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's 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) and recall number Z-2206-2026, then follow Siemens Medical Solutions USA, Inc's recall instructions.

FDA Recall Database: Class II Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono… by Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc recalled 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 on 2026-06-10. FDA classified this action as a Class II recall (recall number Z-2206-2026). Reason for recall: 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.. Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Siemens Medical Solutions USA, Inc
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
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
Classification	Class II
Recall number	Z-2206-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	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.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Siemens Medical Solutions USA, Inc and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-2206-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number Z-2206-2026. If it matches, stop using or distributing it and contact Siemens Medical Solutions USA, Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Siemens Medical Solutions USA, Inc’s FDA history

Argus HQ has recorded 4 total FDA actions tied to Siemens Medical Solutions USA, Inc: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Siemens Medical Solutions USA, Inc recalled 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. FDA's record states the reason for recall as: 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.. The recall.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's 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) and recall number Z-2206-2026, then follow Siemens Medical Solutions USA, Inc's recall instructions.

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Full FDA history for Siemens Medical Solutions USA, Inc

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class II Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono… by Siemens Medical Solutions USA, Inc. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-siemens-medical-solutions-usa-inc-z-2206-2026

MLA

"FDA Recall Database: Class II Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono… by Siemens Medical Solutions USA, Inc." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-siemens-medical-solutions-usa-inc-z-2206-2026.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono… by Siemens Medical Solutions USA, Inc." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-siemens-medical-solutions-usa-inc-z-2206-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_siemens_medical_solutions_usa_inc_z_2206_2026_2026,
  title = {FDA Recall Database: Class II Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono… by Siemens Medical Solutions USA, Inc},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-siemens-medical-solutions-usa-inc-z-2206-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗