FDA DevicesClass II
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Published: June 10, 2026Recall ID: Z-2205-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 98992 |
| Address 1 | 40 Liberty Blvd |
| Code info | UDI: 4056869046877 |
| Postal code | 19355-1418 |
| Report date | 20260610 |
| Product type | Devices |
| 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. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20260309 |
| Center classification date | 20260604 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS and Worldwide