Niobe ES System recalled over fire hazard

Recall date

September 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stereotaxis Inc recalls Niobe ES System, Models 001-006000-1 and 001-006100-1

Recall number

Z-0430-2021

FDA classification

Class II

Brand / firm

Stereotaxis Inc

Sold / distributed

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

Why it was recalled

There is a potential for fire in the inside computer cabinet.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Niobe ES System, Models 001-006000-1 and 001-006100-1