FDA Device recall Z-0430-2021
Niobe ES System, Models 001-006000-1 and 001-006100-1
- FDA Device
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Niobe ES System, Models 001-006000-1 and 001-006100-1 by Stereotaxis, citing there is a potential for fire in the inside computer cabinet.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0430-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-21 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stereotaxis |
| Distribution | 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 |
Product
Niobe ES System, Models 001-006000-1 and 001-006100-1
Reason
There is a potential for fire in the inside computer cabinet.
Identifiers
| code_info | Devices with the following system numbers (serial): 105, 108, 113, 116, 124, 125, 126, 128, 130, 131, 134, 135, 138-14…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0430-2021%22
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