FDA Device recall Z-1216-2019
Neuro Omega System, incorporating HaGuide software
- FDA Device
- Class I
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class I recall of Neuro Omega System, incorporating HaGuide software by Alpha Omega Engineering, citing if cables are improperly connected, current may reach high charge density, causing tissue harm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1216-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-09-04 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Alpha Omega Engineering |
| Distribution | US |
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
If cables are improperly connected, current may reach high charge density, causing tissue harm.
Identifiers
| code_info | Serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04,…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1216-2019%22
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