ARTIS pheno recall
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Why was ARTIS pheno 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 4056869046877
- Product
- ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Distribution
- US and Worldwide
- Recall date
- June 10, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)