Steris VividImage 32 4K without decoderRecalls & reported problems
Barco NV · VividImage 32 4K without decoder · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415334051119), received between Jul 27, 2026 and Jul 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Display or Visual Feedback 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback 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.
InjuryJul 27, 2026Display or Visual Feedback Problem
The user facility reported the monitor to their Vividimage 4K Surgical Display was not displaying images. Report of procedure delay. No report of injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005853 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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