Lumenis Pulse 120H Lumenis Pulse Moses 2.0(INT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07290109145150), received between Feb 21, 2023 and Sep 21, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847389 ↗
• MalfunctionJul 27, 2026Output below Specifications; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045714 ↗
• MalfunctionJul 16, 2026Communication or Transmission Problem

  It was reported that the device did not recognize the fiber due to debris on the fiber port threads. The procedure was not completed due to this event. There were no patient complications reported. This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841740 ↗
• MalfunctionJun 2, 2026Nonstandard Device; Overheating of Device

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE LASER CEASED OPERATING DESPITE THE FOOT PEDAL BEING ACTIVELY ENGAGED. THE FIBER WAS OBSERVED TO BE HOT AT THE CONNECTOR AND COULD NOT BE REMOVED FROM THE CONSOLE, WHERE IT REMAINED STUCK. ADDITIONALLY, THE DEBRIS SHIELD WAS NOTED TO BE CLOUDY. DUE TO THE INABILITY TO SAFELY REMOVE THE FIBER AND CONTINUE THE PROCEDURE, THE CASE WAS ABORTED. THE PROCEDURE WAS CANCELLED WITHOUT COMPLICATION AND HAS BEEN RESCHEDULED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366981 ↗
• MalfunctionMay 19, 2026Smoking

  IT WAS REPORTED THAT THE CONSOLE WAS SMOKING, IT WENT THROUGH 3 LASER FIBERS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25213070 ↗
• MalfunctionMay 11, 2026Smoking; Communication or Transmission Problem; Infusion or Flow Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE EMITTED A BURNING SMELL, AND THE ERROR 188 (COOLING SYSTEM ERROR COOLING FLOW SWITCH ERROR) WAS DISPLAYED. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT PATIENT COMPLICATIONS. DURING VISUAL INSPECTION IT WAS FOUND THAT THE CERAMIC FUSE HOUSING AND ADAPTER, 15A OF COOLING SYSTEM WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25140164 ↗
• MalfunctionMar 25, 2026Nonstandard Device; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE DISPLAYED ERROR CODE 153 (LASER DECK - SHUTTER NOT CLOSED), AND 156 (LASER DECK - ATTENUATOR TEST FAIL). THE PATIENT COULD NOT BE OPERATED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693991 ↗
• MalfunctionFeb 18, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF PROSTATE, THE CONSOLE PROMPTED ERROR CODE 188 (COOLING SYSTEM ERROR-COOLING FLOW SWITCH ERROR). AS A RESULT, THE PROCEDURE WAS CANCELLED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405732 ↗
• MalfunctionFeb 7, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE PRESENTED ERROR 188 DURING PROCEDURE, AND THAT THE PROCEDURE WAS NOT COMPLETED. 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 21333480 ↗
• MalfunctionFeb 4, 2025Smoking; Defective Device; Smoking; Defective Device

  IT WAS REPORTED THAT THE FIBER WAS STUCK, AND THE FIBER PORT NEEDS TO BE REPLACED. IN ADDITION, THERE WAS A SMOKING SMELL. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT INVOLVEMENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307178 ↗
• MalfunctionJan 20, 2025Smoking; Device Displays Incorrect Message; Smoking; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE PROCEDURE, A BURNING SMELL WAS NOTICED, AND ERRORS 188 AND 58 DISPLAYED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191591 ↗
• MalfunctionDec 18, 2024Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CONSOLE BREAKS THE FIBERS AND THERE ARE SPARKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20965767 ↗
• MalfunctionDec 13, 2024Smoking; Smoking

  IT WAS REPORTED THAT THE CONSOLE PRETEST WAS PERFORMED SUCCESSFULLY, THEN THE CONSOLE WAS TURNED OFF. AFTER APPROXIMATELY 30 MINUTES, THE LASER WAS TURNED ON WITH THE KEY IN THE OFF POSITION, THE CONSOLE WAS SWITCHED OFF AND REBOOTED. THEN, SMOKE AND A BURNING CHEMICAL SMELL WERE NOTICED. THE LASER WAS NOT FIRED, AND NO ERRORS WERE RECORDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925588 ↗
• MalfunctionOct 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SYSTEM APPEARS TO FIRE WITHOUT PRESSING THE FOOT PEDAL. THE SYSTEM WAS REBOOTED, AND IT CONTINUED TO FUNCTION NORMALLY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL CONSOLE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423391 ↗
• MalfunctionAug 28, 2024Device Displays Incorrect Message; Physical Resistance/Sticking; Device Displays Incorrect Message; Physical Resistance/Sticking

  IT WAS REPORTED THAT ERROR 262: "LASING AND SAFETY-FIRE ENABLE DURATION FAIL (HV PMCU FPGA SAFETY ERROR)" DISPLAYED, AND THE UNIT KEPT CONTINUOUSLY LASING AFTER RELEASING THE FOOT PEDAL AND STANDBY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092473 ↗
• MalfunctionMay 26, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERRORS 251: "CASE SAVE MODE", 254: "LASING PARAMETERS OUT OF LIMIT", 269: "LASING AND SAFETY-WARM-UP FAILED TO GET TO THE THRESHOLD" AND 253: "LASING AND SAFETY-PYRO LOW LIMIT FAIL" DISPLAYED DURING TWO PROCEDURES. FOR ONE PROCEDURE, THE CONSOLE WAS RESTARTED AND THE PROCEDURE COULD BE COMPLETED WITHOUT PATIENT COMPLICATIONS. FOR THE SECOND ONE, THE PROCEDURE COULD NOT BE COMPLETED. 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 19398935 ↗
• MalfunctionMay 22, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A HOLEP PROCEDURE THE CONSOLE SHOWED CASE SAVER MODE AND THE PROCEDURE WAS NOT COMPLETED. 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 19374365 ↗
• MalfunctionFeb 19, 2024Appropriate Device Problem Term/Code Not Available; Noise, Audible; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE WAS MAKING NOISES AND THE STOP BUTTON WAS IN A STUCK POSITION. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18732256 ↗
• MalfunctionSep 14, 2023Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT THE LASER CONSOLE PROMPT, CASE SAVER MODE. THE PATIENT HAD ALREADY BEEN SEDATED AT THE TIME OF THE CONSOLE PROMPT. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT AND THERE WAS NO SERIOUS INJURY TO THE PATIENT. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749216 ↗
• MalfunctionAug 22, 2023Defective Device; Firing Problem; Defective Device; Firing Problem

  IT WAS REPORTED THAT DURING HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE THE MOSES FAILED TO FIRE BECAUSE THE 45-DEGREE MIRROR BURNED. THE PROCEDURE WAS CONTINUED USING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) BUT ONLY HALF OF THE PROSTATE WAS TREATED. THE OTHER HALF WILL BE TREATED WHEN THE CONSOLE IS AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED. 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 17597856 ↗
• MalfunctionFeb 21, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE CONSOLE DEVICE DISPLAYED ERROR 58 AND ERROR 270 AND STOPPED WORKING. THE PROCEDURE WAS CANCELED. IT WAS LATER REPORTED THAT IT TURNED OUT TO BE A USER ERROR, THE KEY WAS NOT TURNED ON PROPERLY AND THE EVENT HAD RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR A CANCELLED PROCEDURE WITH THE PATIENT UNDER SEDATION OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415052 ↗