Data Foundry

Medical device recalls 2018

XLTEK EMU40EX EEG Headbox — Class II medical device recall Z-2570-2018

Terminated recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), reported 2018-08-08, distributed in AL, CA, CO, CT, FL, GA, IA, ID…. Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout

Recall numberZ-2570-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmNatus Neurology DBA Excel Tech., Ltd. (XLTEK), Oakville, N/A, Canada
Recall initiated2018-05-15
Classified2018-07-28
Reported by FDA2018-08-08
Terminated2024-05-06
DistributedAL, 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
Countries outside the USCA, CN, CY, DE, ES, GB, HK, IT, MX, SA
Quantity462 units
Reason classesspecification failure
Model numbers002933, 10406

Product

XLTEK EMU40EX EEG Headbox

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2570-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.