Recall Z-1216-2019 ยท GZL Electrode, Depth
Alpha Omega Engineering
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
| Date | May 6, 2019 (initiated Sep 4, 2018) |
| Status | Terminated |
| Reason | If cables are improperly connected, current may reach high charge density, causing tissue harm. |
| Root cause | Device Design |
| Action | The firm originally notified customers of the issue via email on September 4, 2018. Also, another updated notification Urgent Field Safety Notice, Neuro Omega system, DATE March 4, 2019, Field Advisory Note [FAN] Attention: Details on affected devices: Neuro Omega system with: Catalogue number: (Neuro Omega) NOM-000000-00 + (Drive) 750-000020-00 + (EMG) 750-000010-00 + (EEG) 750-000010-12 Software version number: Any, clarifying that the issue only occurred in a triple-fault condition. |
| Quantity | 29 |
| Distribution | US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA |
| FDA record | Open on fda.gov |