- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Affected products (lot / model / serial)
- ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.
- Units affected
- U.S. 758, OUS 2077
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Malvern, PA, United States
- Recall type
- FDA Mandated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1653-2026
- Recall initiated
- March 10, 2026
- FDA classification date
- April 7, 2026
- FDA report date
- April 15, 2026
- FDA event ID
- 98675
- Last updated on HTM Vibe
- July 24, 2026