RadiaLux™ 50-101-1 (UDI 00763000432799)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000432799), received between Apr 18, 2023 and Apr 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEBRIS WAS FOUND ONLY IN THE HANDPIECE PACKAGING WHICH WAS NEVER OPENED, NO DAMAGE TO THE INSTRUMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845024 ↗
• MalfunctionNov 13, 2025Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT A HANDPIECE WAS FOUND TO HAVE A BROWN SUBSTANCE ON IT IMMEDIATELY UPON REMOVAL FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539573 ↗
• MalfunctionMar 13, 2025Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A GENERATOR. IT WAS REPORTED THAT THE DUST PARTICLE FOUND IN STERILE PACKAGING. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591743 ↗
• MalfunctionApr 18, 2023No Device Output; No Device Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT  WHEN PACKAGING WAS OPENED, THE ITEMS WERE BROKEN AND DID NOT WORK. THIS OCCURRED WITH TWO OF THE ITEMS.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762784 ↗
• MalfunctionApr 18, 2023Break; No Device Output; Break; No Device Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT  WHEN PACKAGING WAS OPENED, THE ITEMS WERE BROKEN AND DID NOT WORK. THIS OCCURRED WITH TWO OF THE ITEMS.  THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762776 ↗