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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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