[Recalled] Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue. — If cables are improperly connected, c
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Alpha Omega Engineering |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1216-2019 |
| Country of notice | Israel |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 04 September 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: If cables are improperly connected, current may reach high charge density, causing tissue harm.
This Class I recall concerns device products distributed in Israel and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.