Alpha Omega Engineering Recalls Neuro Omega Systems Due to Tissue Harm Risk
Alpha Omega Engineering is recalling 29 Neuro Omega Systems because improperly connected cables may cause high charge density, leading to tissue harm.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (tissue harm from electrical current) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Alpha Omega Engineering is recalling 29 units of the Neuro Omega System, which incorporates HaGuide software. These devices are used for neurological and neurosurgical purposes to monitor, record, and display bioelectric signals, as well as to stimulate nerves and brain tissue.
The recall was initiated because if cables are improperly connected, current may reach high charge density, which can cause tissue harm. The affected units were distributed nationwide in the United States, specifically in Alabama, Arizona, California, Colorado, Georgia, Illinois, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Ohio, Pennsylvania, Rhode Island, Texas, and Virginia.
Healthcare facilities and users should stop using the affected Neuro Omega Systems immediately. Affected units can be identified by the following serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.
The recalled product
- Product
- Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
- Manufacturer
- Alpha Omega Engineering
- Affected units
- 29
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)
- Serial numbers: 113
- 115
- 116
- 118
- 123
- 121
- 125
- 129
- 130
- 137
- 138
- 141
- 140
- 146
- 149
- 147
- 156/04
- 159/04
- 163/04
- 161/04
Distribution
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