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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82540

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 04, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Alpha Omega Engineering

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.

Z-1216-2019
Recall number
Z-1216-2019
Initiated
September 04, 2018
Classification
Class I
Status
Terminated
Recalling firm
Alpha Omega Engineering
Quantity
29

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
If cables are improperly connected, current may reach high charge density, causing tissue harm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

If cables are improperly connected, current may reach high charge density, causing tissue harm.

Code information

Serial numbers: 113, 115, 116, 118, 123, 121, 125, 129, 130, 137, 138, 141, 140, 146, 149, 147, 156/04, 159/04, 163/04, 161/04, 167, 175/06, 176/06, 177/06, 180/06, 182/06, 185/06, 188/06, and 189.

Distribution pattern

US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA