Radiance 90X0672Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851455007836), received between Jan 13, 2020 and Sep 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 13, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE ALL-IN-ONE CCU+LIGHT ROW AND THE RADULTRA32"HDMEDICAL DISPLAY WERE NOT WORKING, THE SCREEN WAS DARK AND THERE WAS NO IMAGE, DID A TROUBLESHOOTING TURNING ON/OFF AND LOGGING OFF THE CAMERA, BUT STILL DIDN¿T WORK. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583451 ↗