Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and displ
FDA device recall Z-1216-2019 · posted 2019-05-06 · Terminated
Recall details
- Recalling firm
- Alpha Omega Engineering
- Reason for recall
- If cables are improperly connected, current may reach high charge density, causing tissue harm.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GZL
- Quantity affected
- 29
- Distribution
- US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA
- Date initiated
- 2018-09-04
- Date posted
- 2019-05-06
- Date terminated
- 2020-11-03
- Location
- Nazerat Illit, Israel
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Neuro Omega System (K171581) | Alpha Omega Engineering , Ltd. | 2017-12-22 |
| NEURO OMEGA SYSTEM (K123796) | Alpha Omega Engineering , Ltd. | 2013-04-05 |