Siemens ARTIS imaging systems may display an inflated patient dose reading
Siemens ARTIS pheno and ARTIS Icono systems may sporadically display a major increase in the x-ray dose applied, although the actual dose applied remains within system settings and regulatory limits.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source states the actual applied dose remains correct and within regulatory requirements, so the defect is an erroneous readout rather than a patient exposure, placing it at the Moderate level.
Plain-English summary
Siemens is recalling ARTIS pheno and ARTIS Icono biplane, floor and ceiling interventional imaging systems, model numbers 10849000, 11327600, 11328100 and 11327700. The action covers 758 units in the United States and 2,077 outside the United States.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. According to the manufacturer, despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions and with the applicable regulatory requirements. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The systems are installed in hospital interventional suites rather than sold to consumers.
Facilities operating an affected system should follow the instructions issued by Siemens and contact their service representative with questions about affected dose records.
The recalled product
- Product
- ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
- Manufacturer
- Siemens Medical Solutions USA, Inc
Distribution
Distributed nationwide across the United States.
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