FDA Medical devices recall ·
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system recall
- Recall number
- Z-2205-2026
- Date
- (initiated March 9, 2026)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 4056869046877
Distribution
US and Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2205-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.