Stereotaxis Niobe ES System Recalled for Potential Fire Hazard
Stereotaxis Inc is recalling 121 Niobe ES Systems due to a potential fire risk in the internal computer cabinet.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a potential fire hazard, which constitutes a significant injury risk. Per the rubric, risk-of-harm products with significant injury potential (fire) are classified as Severe.
Plain-English summary
Stereotaxis Inc is recalling 121 units of the Niobe ES System, Models 001-006000-1 and 001-006100-1. The recall is being conducted because there is a potential for fire in the inside computer cabinet of the device.
The affected devices were distributed in the United States and internationally. US distribution included 28 states, while international distribution covered the EU, China, Australia, Singapore, Canada, South Africa, and Japan. Specific serial numbers for the affected units are listed in the official recall documentation.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or fires that have occurred. Users should refer to the official FDA recall notice for specific corrective actions.
The recalled product
- Product
- Niobe ES System, Models 001-006000-1 and 001-006100-1
- Manufacturer
- Stereotaxis Inc
- Hazard
- Affected units
- 121
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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