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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80239

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

Open FDA event record

Event summary

Timeline bucket
May 15, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

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

XLTEK EMU40EX EEG Headbox

Z-2570-2018
Recall number
Z-2570-2018
Initiated
May 15, 2018
Classification
Class II
Status
Terminated
Quantity
462 Units Total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.

Code information

Part Numbers: 10406, 002933

Distribution pattern

USA Distribution: AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, ,RI, SC, TN, TX, UT, VA, WA, WI. World wide Distribution: Canada, China, Cyprus, Germany, Hong Kong, Italy, Mexico, Saudi Arabia, Spain, United Kingdom