Novii Interface 107-PT-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682142700), received between Sep 13, 2024 and Sep 13, 2024 — classified as 1 death.

2 other recalls cover devices cleared under the same FDA submission (K140862); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HOSPITAL ALLEGED A FETAL DEATH AFTER THE CLINICIAN DID PROLONGED TROUBLE SHOOTING WHILE A FETAL MONITOR DEVICE WAS IN USE. IT WAS REPORTED BY THE HOSPITAL THAT THE DEVICE DID NOT FAIL, AND IT WAS ALLEGED THAT THE EVENT WAS CAUSED BY USE ERROR BY THE ATTENDING NURSE. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 20210908 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140862. One submission often covers many models, so check the product and lot details in each record.

• Z-1292-2018 · Dec 15, 2017 · Terminated
  Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing th
• Z-2588-2017 · Apr 28, 2017 · Terminated
  Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output