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microTargeting™ Guideline 4000 LP+™ MT-LPP-00271Recalls & reported problems

Fhc, Inc. · microTargeting Guideline 4000 LP+ · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263002711), received between Jul 3, 2024 and Jul 3, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K071364); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Convulsion/Seizure1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HOSPITAL WAS USING FHC'S MICROELECTRODE RECORDING (MER) SYSTEM ALONG WITH OUR ELECTRODE AND INSERTION TUBES. THE CUSTOMER WAS RECORDING WHEN THE MER SYSTEM HAD A SPACE ISSUE IN THE MEMORY OF THE LAPTOP DUE TO WINDOWS UPDATES, WHICH CAUSED THE USER TO GET AN ERROR MESSAGE REGARDING 'INSUFFICIENT MEMORY', WHILE TRYING TO DELETE SOME OF THE FILES (TO FREE UP MEMORY) AND REBOOTING THE SOFTWARE, THE PATIENT HAD A SEIZURE. THE CASE WAS CANCELED. LATER THAT DAY, THE CUSTOMER PERFORMED FUNCTIONALITY TESTING ON THE SUBJECT PRODUCT WHERE NO ANOMALIES WERE FOUND. THE PRODUCT WAS NOT RETURNED TO FHC FOR EVALUATION AND IS STILL IN USE AT THE HOSPITAL WITHOUT ISSUE.

    Patient problems: Convulsion/Seizure

    MAUDE report 19670525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071364. One submission often covers many models, so check the product and lot details in each record.

  • Z-1143-2010 · Dec 28, 2009 · Terminated
    FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, Catalog # MT-GL4K. Intended to assist in functional neurological procedures.

Other ELECTRODE, DEPTH devices

All ELECTRODE, DEPTH devices →

Sources and updates

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