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Siemens Medical Solutions USA, Inc recalls Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medi
Recalled February 26, 2020 · FDA recall Z-1339-2020 · Siemens Medical Solutions USA
Hazard
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. · FDA Class II
Units
507
Sold at
US Nationwide distribution.
Description
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Product
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →