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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "If cables are improperly connected, current may reach high charge density, causing tissue harm."
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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