FDA-Device2020-02-26Class II
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 sit
Siemens Medical Solutions USA, Inc
Hazard
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Sold states
US Nationwide distribution.
Affected count
507
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2020Don't want to check this manually?
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