Stereotaxis Niobe ES System Fire Recall: Potential Fire in Computer Cabinet
Stereotaxis recalls Niobe ES System models 001-006000-1 and 001-006100-1 due to potential fire in the computer cabinet. Affected units have specific serial numbers listed in the recall notice.
Use caution until it’s fixed
There is a potential for fire in the inside computer cabinet.
Contact the company
What happened, in plain English
Stereotaxis is recalling certain Niobe ES System models because there's a potential for fire inside the computer cabinet. This could lead to serious injury or property damage if the fire starts. Read more at govinfonow.com/recall/64251-stereotaxis-niobe-es-system-fire-recall-potential-fire-in-computer.
Source Summary by GovInfoNow · govinfonow.com/recall/64251-stereotaxis-niobe-es-system-fire-recall-potential-fire-in-computer · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0430-2021
Cite this page
“Stereotaxis Niobe ES System Fire Recall: Potential Fire in Computer Cabinet.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64251-stereotaxis-niobe-es-system-fire-recall-potential-fire-in-computer. Based on FDA recall #Z-0430-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0430-2021%22&limit=1).
Why it’s dangerous
The system's computer cabinet has a potential for fire, which could start if the device is used improperly or if internal components overheat. This fire risk is particularly concerning in medical environments where equipment is critical for patient safety.
Who’s affected
Users of the Niobe ES System models 001-006000-1 and 001-006100-1 are affected. Medical professionals using these systems in surgical settings are most at risk due to the potential fire hazard.
How to tell if you have this one
Check your Niobe ES System for serial numbers listed in the recall notice: 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.
- Brand
Stereotaxis- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on your Niobe ES System to confirm if it's in the list of affected numbers provided in the recall notice.
Contact Stereotaxis
Reach out to Stereotaxis Inc for further instructions on how to address the potential fire hazard in your device.
Where it went and when
Where it was distributed
Distributed in 28 states, and outside the U.S.
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0430-2021 (September 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0430-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.