RadianceRecalls & reported problems across all models

We found 4 models of Radiance by Nds Surgical Imaging LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 26, 2019 and Apr 30, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Radiance problems

Radiance models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Radiance 90X0670

  Camera, Surgical And Accessories
  19 reports
• Radiance 90X0672

  Camera, Surgical And Accessories
  2 reports
• Radiance 90X0695

  Camera, Surgical And Accessories
  1 report
• Radiance 90X0666

  Camera, Surgical And Accessories
  1 report

Recent Radiance adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionAug 26, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE RAD32" 4K/UHD MEDICAL DISPLAY DID NOT FUNCTION PROPERLY. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE UNIT WOULD NOT POWER ON AND THERE WAS SOME CORROSION ON A CONNECTOR CONNECTING TO AN INTERNAL POWER BOARD. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370547 ↗
• MalfunctionAug 19, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RAD32" 4K/UHD MEDICAL DISPLAY DEVICE WAS BLURRY AND HAD STATIC. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343793 ↗
• MalfunctionJun 23, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RAD32" 4K/UHD MEDICAL DISPLAY DEVICE SUDDENLY BLACKED OUT. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050370 ↗
• MalfunctionDec 31, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A PART OF THE SCREEN ON THE MEDICAL DISPLAY DEVICE DID NOT HAVE BRIGHTNESS. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101609 ↗
• MalfunctionNov 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE CALL THAT DURING SET UP FOR THE EVALUATION THE SALES REP NOTICED THAT THE RAD32" 4K/UHD MEDICAL DISPLAY MONITOR IMAGE WAS GRAINY AND THE CCS IS NOT RESPONDING. NO CASE IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920994 ↗
• MalfunctionNov 10, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT THREE RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY HAVE COLOR BAR ISSUES DURING SET UP FOR IN-SERVICE. NO PROCEDURE OR PATIENT INVOLVEMENT. THESE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10820120 ↗
• MalfunctionNov 10, 2020Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT THREE RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY HAVE COLOR BAR ISSUES DURING SET UP FOR IN-SERVICE. NO PROCEDURE OR PATIENT INVOLVEMENT. THESE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10820085 ↗
• MalfunctionNov 10, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT THREE RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY HAVE COLOR BAR ISSUES DURING SET UP FOR IN-SERVICE. NO PROCEDURE OR PATIENT INVOLVEMENT. THESE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10820074 ↗
• MalfunctionSep 26, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING A KNEE ARTHROSCOPY A RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY FAILED. SCREEN BUTTONS DO NOT ALWAYS WORK AND THE SCREEN SOMETIMES PRODUCES A JUMPY IMAGE FLASHING IN AND OUT. THERE WAS A DELAY OF LESS THAN 5 MINUTES AND NO PATIENT CONSEQUENCES. THE CASE WAS COMPLETED BY SHUTTING DOWN THE VIDEO TOWER AND RESTARTING IT.

  Patient problems: Not Applicable

  MAUDE report 10590902 ↗
• MalfunctionSep 16, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY MANAGER VIA EMAIL THAT 3 MONITORS FAILED. FIRST RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY AND RADIANCE ULTRA 32¿ HD MEDICAL DISPLAY HAD INTERMITTENT POWER. SECOND RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY PRESENTED IMAGE DEGRADATION, SHARPNESS AND COLOR IS NOT AS IT ONCE WAS. NO REPLACEMENTS ARE NEEDED. NO SURGICAL INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10543513 ↗
• MalfunctionSep 3, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT PRE-OPERATIVELY TO AN UNKNOWN PROCEDURE, WHILE USING AN ALL-IN-ONE CCU+LIGHT SOURCE AND A RADIANCE ULTRA 32¿ HD MEDICAL DISPLAY, THERE WAS IMAGE ONLY ON THE BOTTOM OF THE SCREEN. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487024 ↗
• MalfunctionAug 24, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT THE RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY PROVIDED AS REPLACEMENT OF (B)(4) IS ALSO PROVIDING THE IMAGE WITH TOO MUCH GLARE. NO PROCEDURE OR PATIENT WAS INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442916 ↗
• MalfunctionAug 14, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE ONE OF THE DOCTORS COMPLAINED ABOUT SIGNIFICANT GLARE COMING FROM THE RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY ON THE SECONDARY DISPLAY. UPON FURTHER INVESTIGATION, THE SALES CONSULTANTS AND CLINICAL EVALUATOR DETERMINED THAT THE MONITOR ON THE TOWER AND THE MONITOR ON THE SECONDARY DISPLAY SEEM TO HAVE SCREENS THAT ARE MADE FROM TWO DIFFERENT MATERIALS. THE ONE ON THE TOWER WAS MADE OF A MORE PLASTIC LIKE MATERIAL AND WAS NOT HAVING ANY GLARE ISSUES, THE ONE ON THE SECONDARY DISPLAY WAS MADE OF GLASS AND HAD THE GLARE ISSUES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10409762 ↗