Siemens is recalling 603 ARTIS icono angiography systems (floor, ceiling, and biplane models) because of a technical defect in the x-ray collimator. In rare instances, the first x-ray taken after registering a patient may use incorrect copper filtering, which can deliver a higher dose of radiation than the operator intended. These systems are specialized medical imaging devices used for diagnostic and interventional procedures in both adults and children. Siemens is notifying affected facilities by letter to address this software and hardware communication issue.
The system may deliver an unintended, higher radiation dose rate during the first x-ray release, potentially exposing patients and medical staff to unnecessary radiation levels.
Manufacturer notification and potential system adjustment
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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