Reported Nov 18, 2020 · Terminated

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

Stereotaxis Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stereotaxis Inc · 4320 Forest Park Ave Ste 100 · Saint Louis, MO · 63108-2979

Is this the product you have?

  • Niobe ES System, Models 001-006000-1 and 001-006100-1
Lot codes and dates
  • Devices with
  • the following system numbers (serial)
    • 105
    • 108
    • 113
    • 116
    • 124
    • 125
    • 126
    • 128
    • 130
    • 131
    • 134
    • 135
    • 138-142
    • 144
    • 147
    • 149
    • 154
    • 158
    • 162
    • 163
    • 169
    • 170
    • 172-174
    • 177-179
    • 181-183
    • 185
    • 187
    • 189
    • 190
    • 192-202
    • 205
    • 206
    • 208-210
    • 212
    • 214-222
    • 224-229
    • 231
    • 232
    • 235-242
    • 244
    • 245
    • 249
    • 251-256
    • 258-278
    • 280-284
    • 286
    • 287
    • 288
    • 290
    • and 297
Amount recalled
121

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 13, 2023 · Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.