Neuro Omega System — Class I medical device recall Z-1216-2019
Terminated recall by Alpha Omega Engineering, reported 2019-05-15, distributed nationwide. If cables are improperly connected, current may reach high charge density, causing tissue harm.
| Recall number | Z-1216-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alpha Omega Engineering, Nazerat Illit, N/A, Israel |
| Recall initiated | 2018-09-04 |
| Classified | 2019-05-06 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 29 |
| Serial numbers | 113, 115, 116, 118, 121, 123, 125, 129, 130, 137, 138, 140, 141, 146, 147, 149, 156/04, 159/04, 161/04, 163/04, 167, 175/06, 176/06, 177/06, 180/06 and 4 more |
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.
Reason for recall
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1216-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.