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Lumenis Pulse, Moses 2.0 (DOM)Recalls & reported problems

Lumenis Ltd. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290109147185), received between Jun 11, 2024 and Jun 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Defective Device1
  • Output below Specifications1
  • Physical Resistance/Sticking1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 26, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

    IT WAS REPORTED THAT DURING A PROCEDURE THE LASER IS NOT WORKING PROPERLY. THE RESIDENT WAS LASERING, TOOK HIS FOOT OFF THE PEDAL, AND THE LASER STOPPED EMITTING ENERGY, BUT CONTINUED INDICATING LASING ACROSS THE SCREEN. THE SCREEN WAS NOT RESPONSIVE WHEN IT WAS TRIED TO TURN THE LASER OFF. THE EMERGENCY RED STOP BUTTON WAS USED, AND IT DID NOT WORK TO STOP THE LASER. THE DEVICE WAS ENDED UP UNPLUGGING IT FROM THE WALL TO GET IT TO TURN OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22342873 ↗
  • MalfunctionApr 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FOOTSWITCH IS STICKING WHEN PRESSED, CAUSING THE MACHINE TO FLASH THE ORANGE LIGHT AND SAYS LASING BUT IT WAS NOT ACTUALLY LASING. THE E-STOP WAS PUSHED, RESTARTED UNIT AND THE PROCEDURE WAS COMPLETED WITHOUT USING THE FOOTSWITCH. THE PATIENT WAS STABLE UNDER GENERAL ANESTHESIA.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21859411 ↗
  • MalfunctionJun 11, 2024Output below Specifications; Output below Specifications

    IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE PRESENTED A DIMINISHED LASER ENERGY, CAUSING NOT ABLATING TISSUE AS IT SHOULD. THE PHYSICIAN REPORTED THE CONSOLE PRESENTED LOW POWER. THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19511590 ↗

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Sources and updates

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