Niobe ES System — Class II medical device recall Z-0430-2021
Terminated recall by Stereotaxis Inc, reported 2020-11-18, distributed in AZ, CA, CO, CT, FL, GA, ID, IL…. There is a potential for fire in the inside computer cabinet.
| Recall number | Z-0430-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stereotaxis Inc, Saint Louis, MO, United States |
| Recall initiated | 2020-09-21 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2023-11-13 |
| Distributed | AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MI, MN, MO, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI |
| Countries outside the US | AU, CA, CN, JP, SG, ZA |
| Quantity | 121 |
| Serial numbers | 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 and 25 more |
| Model numbers | 001-006000-1, 001-006100-1 |
Product
Niobe ES System, Models 001-006000-1 and 001-006100-1
Reason for recall
There is a potential for fire in the inside computer cabinet.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0430-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.