Class I — Alpha Omega Engineering
| Recalling firm | ALPHA OMEGA ENGINEERING LTD. |
|---|---|
| Registered facility | ALPHA OMEGA ENGINEERING LTD. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | If cables are improperly connected, current may reach high charge density, causing tissue harm. |
| 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. |
| Quantity | 29 |
| Distribution | US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA |
| Initiated | 2018-09-04 |
| Classified | 2019-05-06 |
| Terminated | 2020-11-03 |
| Recall number | Z-1216-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Alpha Omega Engineering (Z-1216-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82540/
Alerts for ALPHA OMEGA ENGINEERING LTD.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.