Reported May 15, 2019 · Terminated
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and…
Alpha Omega Engineering
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Alpha Omega Engineering · PO Box 810, Haavoda Street · Nazerat Illit, N/A · N/A
Is this the product you have?
- Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
- Lot codes and dates
- Serial numbers
113115116118123121125129130137138141140146149147156/04159/04163/04161/04167175/06176/06177/06180/06182/06185/06188/06and 189
- Serial numbers
- Amount recalled
- 29
Where it was sold
Why it was recalled
Stop using this product now
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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