FDA Class II Recall: ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system by Siemens Medical Solutions USA, Inc

Key facts

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 pheno, Model 10849000. interventional fluoroscopic x-ray system -- and the recall number Z-2205-2026. 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. 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 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 pheno, Model 10849000. 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-2205-2026 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. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

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

Has Siemens Medical Solutions USA, Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Siemens Medical Solutions USA, Inc, including 4 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2205-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

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.

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