Siemens ARTIS Icono Biplane and Floor Systems Recalled for Software Errors
Siemens is recalling 41 ARTIS Icono systems with software version VE20B due to misleading error messages and manual gaps that may cause procedure termination.
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 recall is classified as FDA Class II. The hazard involves software errors and documentation gaps that may lead to procedure termination, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 41 units of the ARTIS Icono biplane (Model 11327600) and ARTIS Icono floor system (Model 11327700) equipped with software version VE20B. These devices are intended for single and biplane diagnostic imaging and interventional procedures. The recall affects units distributed nationwide in the United States.
The recall is due to misleading error messages and a gap in the Operator Manual. These issues affect system error management, erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. The source text notes that these issues may cause procedures to be terminated and performed on an alternative x-ray system.
No specific injuries or illnesses are reported in the source text. Affected serial numbers are listed in the agency's recall record. Users should contact Siemens Medical Solutions USA, Inc. for further instructions on resolving the software and documentation issues.
The recalled product
- Product
- ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 41
Distribution
Distributed nationwide across the United States.
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