Siemens Medical Solutions USA, Inc. has recalled 73 ARTIS Pheno VE30A and VE40A medical imaging systems because they may capture images with uneven brightness during 3D scans. This defect can lead to inaccurate 3D reconstructions and exposes patients to unintentional, though low-dose, radiation. No injuries or incidents have been reported to date.
The system uses an unregulated radiation dose during rotational scans, which can result in inconsistent image quality and unnecessary radiation exposure for patients during diagnostic procedures.
Device used for 3D acquisitions; recall involves firmware/software issues regarding unregulated medium dose during rotation.
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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