Cerner FetaLink FetaLink200Recalls & reported problems
Cerner Corporation · Class 2
Data updated Oct 18, 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 00853023006227), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Software 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 18, 2026.
Most reported problems
Device problems
- Computer Software Problem1
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.
MalfunctionJan 13, 2021Computer Software Problem; Computer Software Problem
THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S FETALINK®. THIS ISSUE INVOLVES CERNER'S FETALINK AND AFFECTS USERS THAT UTILIZE FETALINK AS A DIAGNOSTIC AID WHICH DISPLAYS THE GRAPHICAL IMAGES OF FETAL AND MATERNAL HEART RATE AND OTHER DATA THAT ARE GATHERED FROM THE MONITORING DEVICES ATTACHED TO THE PATIENT. IN CERNER MILLENNIUM, WHEN THE USER ADDS AN ANNOTATION FOR A FETAL MONITOR THAT IS DISPLAYED IN THE CENTRAL MONITOR PERSPECTIVE WHILE THE PERSPECTIVE IS REFRESHED, THE APPLICATION MAY FREEZE, AND NEW DEVICE DATA MAY NO LONGER BE DISPLAYED. WHEN THIS HAPPENS, ALL DEVICE DATA FOR THE MONITORED LOCATIONS IN THE CENTRAL MONITOR PERSPECTIVE ARE OUT OF DATE, AND NEW DEVICE DATA, INCLUDING ALERTS AND NOTIFICATIONS, ARE NOT DISPLAYED. PATIENT CARE COULD BE ADVERSELY AFFECTED, AS CLINICIANS MAY NOT HAVE ACCESS TO ACCURATE AND UP-TO-DATE MATERNAL AND FETAL MONITORING DATA. THIS INCLUDES FETAL WAVEFORMS, VITAL SIGN CONTAINERS, ALERTS, NOTIFICATIONS, MONITORS POWERED ON OR OFF, OR A CHANGE IN MONITOR ASSOCIATION. THIS COULD RESULT IN PATIENT CARE DELAY. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11163635 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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