Lumenis Pulse 120H (REF GA-0008700D)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109147215), received between Jul 29, 2025 and Nov 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE'S FOOT SWITCH STOPPED FIRING THE FIBER BUT CONTINUED MAKING SOUND, WITH FIRING STILL SHOWING ON THE SCREEN. IT WAS ALSO NOTED THAT THE DEVICE'S EMERGENCY STOP DID NOT STOP THE FIRING, AND THE ISSUE WAS RESOLVED BY SHUTTING DOWN THE CIRCUIT BREAKER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535713 ↗
• MalfunctionJul 29, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE DID NOT HAVE ENOUGH POWER WHEN PERFORMING FINE DUSTING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644991 ↗