X80 / RADiant / PhotoElectric Therapy System RADiant AuraRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060494200084), received between May 19, 2024 and May 19, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON THE (B)(6) 2024, THE ARM JOINT BECAME LOOSE AND THIS CAUSED THE ARM TO DROP. THE RADIATION THERAPIST PUT HER SHOULDER IN THE PATH OF THE ARM TO STOP IT FROM DROOPING FURTHER. NO PATIENT INJURY. PRODUCT PROBLEM: SERVICE VISIT TO THE USER SITE FOUND THE FOLLOWING: MEASURED EXISTING UPPER ARM JOINT TORQUE WITH SHIMS INSTALLED (19.2NM) AS WELL AS LOWER JOINT (18.6NM). TIGHTENED JOINT SCREW TO APPROPRIATE 20NM SETTING. DURING THE TESTING AT THE USER SITE, IT WAS DISCOVERED THAT THE ARM JOINT BRAKE WOULD ENGAGE INTERMITTENTLY (APPROX 7 OF 10 TIMES). TESTED THE BASE UNIT PCB AND DISCOVERED FLICKERING OF LEDS WHEN FAILURE WOULD OCCUR AS IF CARD WAS BEING SHORTED OUT. ALSO NOTICED THE BASE HUB ROTARY BRAKES WERE NOT OPERABLE AT ALL (WOULD NOT DISENGAGE). DURING FAULT FINDING PROCEDURE THE BASE HUB BRAKE RESISTANCE READING WAS BELOW TOLERANCE AT APPROX 15.7 OHMS. CHECKED APPLICABLE BRAKE CABLING FOR DISCREPANCIES (DAMAGED OR CROSS WIRING) AND FOUND NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348479 ↗