Radiance 90X0695Recalls & reported problems
Nds Surgical Imaging LLC · KARL STORZ, RADIANCE ULTRA 32'' 4K, 12G-SDI, SC-WK32-G1B07 · Class 1
Data updated Oct 13, 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 00818089021188), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
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.
MalfunctionOct 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "REPORTED PROBLEM: THE MONITOR'S GLASS SCREEN FELL OFF AND SHATTERED. WAS PREVIOUSLY REPAIRED ON RMA# 200261754 INVOLVING THE LCD SCREEN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17937871 ↗
Other Camera, Surgical And Accessories devices
- HexaVue HexaVue SCC 1.0Black Diamond Video, Inc. · CAMERA, SURGICAL AND ACCESSORIES245 reports
- HexaVue HexaVue IPBlack Diamond Video, Inc. · CAMERA, SURGICAL AND ACCESSORIES80 reports
- Maquet Orchide ARD569204944Maquet Sas · Camera, Surgical And Accessories1 recall2 reports
- BARCO MDSC-8527Barco NV · Camera, Surgical And Accessories1 recall1 report
- Vividimage 4K RLM314K3Black Diamond Video, Inc. · CAMERA, SURGICAL AND ACCESSORIES51 reports
- VidiaPort 4028110Baxter Medical Systems GmbH + Co. KG · CAMERA, SURGICAL AND ACCESSORIES1 recall1 report
- Maquet Orchide ARD568803967Maquet Sas · Camera, Surgical And Accessories1 recall0 reports
- AESCULAP JG910Aesculap AG · CAMERA, SURGICAL AND ACCESSORIES1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page