Recall Z-1216-2019— Alpha Omega Engineering
Class I · Terminated
Class I FDA medical device recall by Alpha Omega Engineering, initiated 2018-09-04, terminated 2020-11-03. It names 2 FDA 510(k) clearances: K171581, K123796. 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..
- Recalling firm
- Alpha Omega Engineering
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-09-04
- Terminated
- 2020-11-03
- Firm location
- Nazerat Illit, N/A, Israel
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.