Class II — Stereotaxis Inc
| Recalling firm | Stereotaxis |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for fire in the inside computer cabinet. |
| Product | Niobe ES System, Models 001-006000-1 and 001-006100-1 |
| Quantity | 121 |
| 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 |
| Initiated | 2020-09-21 |
| Classified | 2020-11-06 |
| Terminated | 2023-11-13 |
| Recall number | Z-0430-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stereotaxis Inc (Z-0430-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86555/
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