Component Neuromonitoring System CNS-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B485CNS3501), received between Jan 26, 2023 and Jan 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K080217); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2023Battery Problem; Battery Problem

  MOBERG RESEARCH, INC. HAS BECOME AWARE OF A COMPLAINT OF THE BACKUP BATTERY INSIDE TWO CNS-350 PRODUCTS WERE LEAKING. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245290 ↗
• MalfunctionJan 26, 2023Battery Problem; Battery Problem

  MOBERG RESEARCH, INC. HAS BECOME AWARE OF A COMPLAINT OF THE BACKUP BATTERY INSIDE TWO CNS-350 PRODUCTS WERE LEAKING. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245279 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080217. One submission often covers many models, so check the product and lot details in each record.

• Z-1338-2023 · Feb 20, 2023 · Open, Classified
  Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurement