Cerner SkyVue® SkyVue4Recalls & reported problems
Cerner Corporation · 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 00853023006074), received between Dec 15, 2022 and Dec 15, 2022 — 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 16, 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.
MalfunctionDec 15, 2022Computer Software Problem; Computer Software Problem
THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM SKYVUE®. THE ISSUE AFFECTS USERS THAT HAVE THE ANNOTATION TRACKING PREFERENCE TURNED ON AND UTILIZE SKYVUE FOR MULTIPLANAR RECONSTRUCTION (MPR) TO VISUALIZE MEDICAL IMAGES. IF AN MPR FAILS TO SAVE WHILE THE USER CLEARS THE PATIENT DATA, THE PREVIOUS PATIENT STUDIES MAY BE DISPLAYED WHEN A NEW PATIENT IS SELECTED FOR INTERPRETATION. WHEN THIS OCCURS, THE MEDICAL RECORD NUMBER AND IMAGES FOR EACH PATIENT ARE CORRECTLY DISPLAYED ON EACH IMAGE. PATIENT CARE COULD BE ADVERSELY AFFECTED IF CLINICIANS REVIEW AN INCORRECT PATIENT STUDY AND CLINICAL DECISIONS ARE MADE BASED ON INCORRECT INFORMATION. PATIENT CARE COULD BE DELAYED AS CLINICIANS MUST EXIT THE APPLICATION AND LOG BACK IN TO RETRIEVE THE CORRECT STUDY. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987622 ↗
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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 13, 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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