Nexstim NBS System 5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06430063200057), received between May 5, 2017 and May 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Image Reversal” (1 report).

1 other recall cover devices cleared under the same FDA submission (K112881); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 5, 2017Image Reversal; Improper or Incorrect Procedure or Method; Image Reversal; Improper or Incorrect Procedure or Method

  THIS IS NEXSTIM'S FIRST MDR AND NEXSTIM WANTS TO SELECT MOST CONSERVATIVE APPROACH. NEXSTIM WANTS TO REPORT IT DESPITE NEXSTIM'S RISK AND REPORTABILITY ASSESSMENT REF: (B)(4) HAS DEMONSTRATED THE EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT TO FDA BECAUSE IT HAS BEEN ALSO REPORTED TO FINNISH COMPETENT AUTHORITY VALVIRA. THE REPORT WAS INITIALLY SENT TO FDA ON MARCH 15, 2017 ON A PAPER FORMAT DUE TO TECHNICAL DIFFICULTIES NEXSTIM HAS HAD WITH SETTING UP FULLY FUNCTIONAL AND VALIDATED ESG PRODUCTION ACCOUNT. THE PAPER FORMAT WAS REJECTED BY FDA AND IT WAS RETURNED TO NEXSTIM (RECEIVED ON APRIL 3, 2017). THE PROBLEM: NEXSTIM HAS BECOME AWARE OF AN ISSUE WITH THE NBS SYSTEM 4 SOFTWARE WHICH ALSO AFFECTS NBS SYSTEM 5 SOFTWARE. WHEN A USER, WHILE COPYING MR IMAGE SERIES INTO THE NBS SYSTEM, ACCIDENTALLY GENERATES DUPLICATE COPY OF ONE OR SEVERAL FILES, NBS SOFTWARE WILL IN CERTAIN CIRCUMSTANCES, INCORRECTLY INTERPRET LEFT-RIGHT ORIENTATION AND DISPLAY THE HEAD 3D MODEL MIRRORED ON THE NBS SYSTEM DISPLAY. IF MR IMAGES ARE TRANSFERRED AS INSTRUCTED AND TRAINED, WITHOUT DUPLICATE COPIES, MIRRORING ON THE NBS DISPLAY WILL NOT HAPPEN. MIRRORING IS LIMITED ONLY TO HOW NBS DISPLAYS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546956 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112881. One submission often covers many models, so check the product and lot details in each record.

• Z-2320-2017 · Mar 14, 2017 · Open, Classified
  NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation Sys