Radiance 90X0670Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00851455007812), received between Dec 26, 2019 and Aug 26, 2021 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (14 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionAug 12, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A KNEE ARTHROSCOPY, WHILE USING A RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY, THE DISPLAY TURNED BLACK AND STOPPED WORKING. EVEN AFTER DOING THE RECOMMENDED TROUBLESHOOTING STEPS AS TURNING SYSTEM OFF AND ON, THE DISPLAY DID NOT HAVE ANY POWER ANYMORE. THE POWERCABLE OR THE PUREVUE SYSTEM IS NOT THE ISSUE, THE DISPLAY ITSELF WAS THE ISSUE. THERE WAS A SURGICAL DELAY OF 45 MINUTES AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10396913 ↗
• MalfunctionJun 22, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT BEFORE SURGERY, AFTER STARTING PURE VUE (RAD32" 4K/UHD MEDICAL DISPLAY), THE SCREEN FLICKERED. TAKING AWAY CAMERA CONNECTION DIDN'T HELP. SHUT DOWN AND RESTART OF CCS (ALL-IN-ONE CCU+LIGHT ROW) WITHOUT CAMERA CONNECTION DIDN'T HELP. ONLY RESTART OF HOLE PURE VUE SYSTEM WITHOUT CAMERA CONNECTION SOLVED FLICKERING. IT OCCURS WHEN CAMERA IS INSERTED IN CCS BEFORE START OF PURE VUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182056 ↗
• MalfunctionMar 19, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT AT THE START OF AN ARTHROSCOPY THE (B)(6) DIDN¿T SHOWED PROPER IMAGING, THE IMAGE WAS FLICKERING AND HAD HORIZONTAL LINES ACROSS THE MONITOR. AFTER SEVERAL POWER CYCLES WITH THE CABLE AND SETTING ALTERATIONS ON THE SYSTEM, IT STARTING WORKING PROPERLY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION FROM THE AFFILIATE CONFIRMED A SURGICAL DELAY DID NOT OCCUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857057 ↗
• MalfunctionMar 13, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE IMAGE OF THE RAD32" 4K/UHD MEDICAL DISPLAY WAS SHAKING HORIZONTALLY, THE INPUT WAS CHANGED TO SDI BUT THE MONITOR REMAINED BLACK, ALSO THE TOUCH BUTTONS WERE NOT RESPONDING, THE RAD32" 4K/UHD MEDICAL DISPLAY WAS INSTALLED ON ANOTHER TOWER TO DOUBLE CHECK IT THE UNIT WAS FAULT, AND THE ISSUE WAS CONFIRMED AS THE UNIT CONTINUE HAVING THE SAME ISSUE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832514 ↗
• MalfunctionJan 28, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A SHOULDER SCOPE PROCEDURE THE RADIANCE 32¿ 4K/UHD MEDICAL DISPLAY AND ALL IN ONE CCU + LIGHT SOURCE, IT WAS NOTICED GREEN SPECKS. ALSO, THE CUSTOMER REPORTED TO THE SALES REP THAT THERE IS FLASHING OF COLOR BARS AND SHAKING SCREENS. THE PROCEDURE WAS COMPLETED THE PROCEDURE BY USING ANOTHER TOWER WITH NO PATIENT HARM BUT THERE WAS A TEN MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT HE SPENT TWO HOURS RE-WIRING, RE-BOOTING, AND TROUBLESHOOTING WITHOUT ANY SUCCESS. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9639211 ↗
• MalfunctionJan 8, 2020Poor Quality Image; Poor Quality Image

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING TESTING OF THE EQUIPMENTS, IT WAS DISCOVERED THAT THE PORT ON THE RAD32" 4K/UHD MEDICAL DISPLAY WAS NOT WORKING. ACCORDING TO THE REPORT, THE CABLE HAD TO BE UNPLUGGED AND PLUGGED OF THE RAD32" 4K/UHD MEDICAL DISPLAY WHICH RESOLVED THE ISSUE. FURTHERMORE, IT WAS DISCOVERED THAT THE MICRO TORNADO HP W HANDCONTROL HAD THE CONNECTOR CAP WAS MISSING. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564368 ↗
• MalfunctionDec 26, 2019Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE RAD32" 4K/UHD MEDICAL DISPLAY DEVICE DID NOT TURN ON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE PRODUCED A VERY POOR AND NON-SHARP IMAGE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521043 ↗