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.
There is a potential for fire in the inside computer cabinet.
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.
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.
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.
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.
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.
Reach out to Stereotaxis Inc for further instructions on how to address the potential fire hazard in your device.
The affected models are Niobe ES System, Models 001-006000-1 and 001-006100-1 with specific serial numbers listed in the recall notice.
The recall notice does not specify a fix or remedy; affected users should contact Stereotaxis Inc for further instructions.
Check your device's serial number against the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send Stereotaxis to request your refund or repair — edit it as you like.
Subject: Recall Z-0430-2021 — Stereotaxis Stereotaxis Hello, I own a Stereotaxis that is covered by recall Z-0430-2021 from Stereotaxis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.