Reported Nov 18, 2020 · Terminated
Niobe ES System, Models 001-006000-1 and 001-006100-1
Stereotaxis Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stereotaxis Inc · 4320 Forest Park Ave Ste 100 · Saint Louis, MO · 63108-2979
Is this the product you have?
- Niobe ES System, Models 001-006000-1 and 001-006100-1
- Lot codes and dates
- Devices with
- the following system numbers (serial)
105108113116124125126128130131134135138-142144147149154158162163169170172-174177-179181-183185187189190192-202205206208-210212214-222224-229231232235-242244245249251-256258-278280-284286287288290and 297
- Amount recalled
- 121
Where it was sold
Why it was recalled
There is a potential for fire in the inside computer cabinet.
This product could cause temporary or reversible health problems — stop using it.
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