Siemens Recalls ARTIS X-Ray Systems Due to Software Issue
Siemens is recalling 133 ARTIS X-ray systems due to a potential software issue that may require terminating planned procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall is classified as FDA Class II, but the source text indicates a potential operational issue requiring procedure termination rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 133 Interventional Fluoroscopic X-Ray Systems, including the ARTIS icono biplane, ARTIS icono floor, and ARTIS pheno models. The recall is due to a potential issue with software version VE20C.
The affected systems are distributed worldwide, including in the United States and various European countries. The specific issue involves a software defect that may cause planned procedures to be terminated and performed on an alternative x-ray system.
Healthcare facilities should contact Siemens for instructions on how to address the software issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 133
Distribution
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Similar recalls
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