Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · Israel · 2018-09-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1216-2019
Date of alert
2018-09-04
Country / jurisdiction
Israel
Risk level
Class I
Risk type
recall
Brand
Alpha Omega Engineering
Product category
device
Product type
Devices
Reported risk: If cables are improperly connected, current may reach high charge density, causing tissue harm.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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