FDA-Device2021-03-31Class II
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Siemens Medical Solutions USA, Inc
Hazard
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Sold states
US Nationwide distribution in the states of MI, KY, TX.
Affected count
29 systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1288-2021Don't want to check this manually?
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