Nazerat Illit, N/A, Israel
Alpha Omega Engineering recalls
1 recall recorded since 2018, most recently on 4 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 4 September 2018
- Terminated
- 3 November 2020
- Reason
- If cables are improperly connected, current may reach high charge density, causing tissue harm.
- Distribution
- US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1216-2019
- Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.