Siemens Medical Solutions USA, Inc: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

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.

Details from the source

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. Distribution: Worldwide - US Nationwide distribution. Quantity: U.S. 758, OUS 2077 Lot/code info: ARTIS pheno UDI: 4056869046877. ARTIS icono biplane UDI: 4056869063317. ARTIS icono ceiling UDI: 4056869295923. ARTIS icono floor UDI: 4056869149325.

UPC codes

4056869046877, 4056869063317, 4056869295923, 4056869149325

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.