Medical imaging system software errors may delay treatment procedures
Siemens Artis icono biplane diagnostic imaging systems may experience software errors affecting block movements and detector rotation, potentially delaying treatment until the system is restarted.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard represents a risk of treatment delay due to software-related loss of functionality in critical medical imaging equipment, but no actual patient harm has been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling Artis icono biplane diagnostic imaging and interventional systems (Model 11327600) distributed nationwide in the United States. The recall affects 94 systems.
Five potential software errors have been identified in the block movements function and manual rotation of the flat detector. These errors may cause limited functionality that is insufficient to continue planned clinical treatment, potentially resulting in treatment delays until the system is restarted.
Healthcare facilities operating affected systems should contact their Siemens representative or the manufacturer for guidance on this issue. The FDA recall number is Z-0985-2022.
The recalled product
- Product
- Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-malfunction
- block-movement-failure
- detector-rotation-failure
Distribution
Distributed nationwide across the United States.
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