FDA DevicesClass II
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, ...
Published: April 15, 2026Recall ID: Z-1653-2026Category: devicesCountry: US
Reason for Recall / Hazard
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
Product Description & Identification
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 98675 |
| Address 1 | 40 Liberty Blvd |
| Code info | ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325. |
| Postal code | 19355-1418 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | U.S. 758, OUS 2077 |
| Reason for recall | During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20260310 |
| Center classification date | 20260407 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.