Siemens Medical Solutions USA, Inc. has recalled 758 ARTIS pheno and ARTIS icono x-ray systems because they may sporadically display a radiation dose level that is significantly higher than what is actually being delivered to the patient. While the system shows an incorrect high dose on the screen, the actual x-ray levels being applied remain within safe, intended settings and regulatory requirements. No injuries or incidents have been reported in connection with this display error.
The system may display a false high radiation dose, which could lead medical staff to prematurely end a necessary procedure or make incorrect clinical decisions based on faulty data, even though the actual radiation dose delivered is correct.
Recall #: Z-1653-2026. Includes 758 units in the U.S. and 2077 units outside the U.S.
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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