NA PE-210AKRecalls & reported problems

Nihon Kohden Corporation · Switch Box for the EEG-1200A · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04931921103937), received between Sep 24, 2025 and Sep 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Electrical /Electronic Property Problem1
Inappropriate/Inadequate Shock/Stimulation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 24, 2025Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SWITCH BOX (PE-210AK, SN: 73) GAVE A "THE ELECTRIC STIMULATOR IS OVERLOADED" ERROR MESSAGE WHILE PERFORMING A CORTICAL MAPPING ON A PATIENT. THEY WERE STIMULATING LB1-LB2 (LEFT ANTERIOR HIPPOCAMPUS) WITH BOTH LOW FREQUENCY AND HIGH FREQUENCY STIMULATION (3 MA FOR BOTH). WITH THE LOW FREQUENCY STIMULATION, THEY HEARD A CRACKLING NOISE COMING FROM THE STIMULATION BOX IN ADDITION TO SEEING ARTIFACTS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23136975 ↗

Device details

UDI-DI	`04931921103937`
Brand	NA
Model	PE-210AK
Company	Nihon Kohden Corporation
Product code	GYC · ELECTRODE, CORTICAL
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Nov 28, 2022

Device type (GMDN): Electroencephalograph

An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

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All ELECTRODE, CORTICAL devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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