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Siemens Medical Solutions USA, Inc recalls ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Recalled November 2, 2022 · FDA recall Z-0119-2023 · Siemens Medical Solutions USA
Hazard
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system. · FDA Class II
Units
140 US
Sold at
Domestic distribution nationwide. Foreign distribution worldwide.
Description
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Product
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →