Radiance 90X0666Recalls & reported problems
Nds Surgical Imaging LLC · KARL STORZ, RADIANCE ULTRA 32.0'' 4K, 12G-SDI, 3D, SC-WK32-G1B07 · Class 1
All models of Radiance (4)
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 00851455007782), received between Apr 30, 2026 and Apr 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Display/Image” (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.
Reports received per month
Most reported problems
Device problems
- No Display/Image1
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.
MalfunctionApr 30, 2026No Display/Image
THE FOLLOWING WAS REPORTED: IMAGE LOSS DURING OPERATION WHILE USING A RUBINA TOWER. BLACK SCREEN REQUIRING A SYSTEM REBOOT. ON-SITE INTERVENTION. THE TESTS CARRIED OUT SUGGEST THAT THE ISSUE ORIGINATES FROM EITHER THE TC201 OR THE TC304. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049596 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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