ARTIS pheno recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIOngoing
Summary: Siemens Medical Solutions USA, Inc is recalling ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system. Reason: 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 is being recalled
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US and Worldwide
How to tell if yours is affected
UDI: 4056869046877
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2205-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 9, 2026 |
| Reported | June 10, 2026 |
| Company | Siemens Medical Solutions USA, Inc |
| Company location | Malvern, PA, United States |
| Initiated by | FDA Mandated |
More recalls from Siemens Medical Solutions USA, Inc · all medical device recalls · recalls from March 2026