FDA-Device2020-11-18Class II
Niobe ES System, Models 001-006000-1 and 001-006100-1
Stereotaxis Inc
Hazard
There is a potential for fire in the inside computer cabinet.
Sold states
US and OUS distribution: US - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA OUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan
Affected count
121
Manufactured in
4320 Forest Park Ave Ste 100, Saint Louis, MO, United States
Products
Niobe ES System, Models 001-006000-1 and 001-006100-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0430-2021Don't want to check this manually?
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