Lumenis Pulse 30H (REF GA-2003322)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07290109145983), received between Jan 20, 2023 and Aug 11, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Output below Specifications

  It was reported that during a Capital Equipment Service, it was found a decrease in output value due to age-related degradation of the Brick. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202729 ↗
• MalfunctionMar 30, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING PROCEDURE AND AFTER SEDATION OF THE PATIENT, THE CONSOLE ISSUED ERROR CODE 4 (FOOTSWITCH FAULT). THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714965 ↗
• MalfunctionMar 16, 2026Output below Specifications

  IT WAS REPORTED THAT DURING PREPARATIONS, THE CONSOLE SEEMS TO HAVE LOW POWER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603889 ↗
• MalfunctionDec 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PREPARATION POST-SEDATION, THE CONSOLE DISPLAYED ERROR CODES 49 PYRO MAIN NOT EQUAL TO PYRO SAFE AND ERROR CODE 54 SW AUTOCAL FAULT: N=1 / NOT DONE: N=2. THE PROCEDURE WAS DISCONTINUED DUE TO DEVICE DEFECT. THERE WAS NO PATIENT COMPLICATION. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880421 ↗
• MalfunctionDec 10, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE'S LASER OUTPUT WAS DECREASING. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774355 ↗
• MalfunctionOct 29, 2025Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT A LOUD NOISE WAS HEARD FROM THE DEVICE, FOLLOWED BY SMOKE FROM THE REAR PART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420548 ↗
• MalfunctionAug 13, 2024Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ERROR 17: "OVERHEATING ALERT! OVER TEMPERATURE (49 C) THERMAL SWITCH" DISPLAYED. THE FAN SEEMED TO NOT BE ROTATING. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978276 ↗
• MalfunctionAug 9, 2024Overheating of Device; Defective Device; Overheating of Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FAN WAS NOT SPINNING, AND AN OVERHEATING ERROR WAS DISPLAYED. DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT HAS BEEN REPORTED WITH A PROCEDURE WHICH ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950408 ↗
• MalfunctionJun 30, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT CONSOLE WAS UNABLE TO BE USED AS THE READY BUTTON COULD NOT BE PRESSED EVEN IF THE FIBER IS CONNECTED. THE CONSOLE WAS REBOOTED BUT STILL DID NOT WORK, LEADING TO THE CANCELLATION OF THE PROCEDURE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240205 ↗
• MalfunctionJan 20, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR CODE 2- SHUTTER ERROR, OCCURRED. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR THE FOLLOWING WEEK. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215014 ↗