Siemens Medical Solutions USA, Inc. has recalled several ARTIS angiography and interventional fluoroscopic x-ray systems due to a software communication error. In very rare instances, the communication between the radiation dose sensor and the system software fails, which can cause the system to incorrectly report that a high dose of radiation was applied. This recall affects various ARTIS models used for imaging and interventional procedures in clinical settings. No injuries or incidents have been reported to date.
A communication failure between the dose sensor and the software can lead to inaccurate reporting of radiation doses. If clinical decisions are based on these incorrect high-dose reports, it could lead to unnecessary post-procedure monitoring or changes in patient care plans based on false data.
Used for cardiac angiography, neuro-angiography, general angiography, and more. Recall # Z-2019-2025.
Recall # Z-2020-2025.
Recall # Z-2021-2025.
Recall # Z-2022-2025.
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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