FDA-Device2020-08-12Class II
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Siemens Medical Solutions USA, Inc
Hazard
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
Sold states
US Nationwide distribution.
Affected count
512 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2758-2020Don't want to check this manually?
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