Lumenis Pulse 120H Lumenis Pulse P120 30 AmpRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07290109145518), received between Jan 2, 2024 and Mar 9, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 23, 2025Class IIOpen, Classified

   The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.

   Z-1290-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Output below Specifications

  IT WAS REPORTED THAT THE DEVICE WAS OPERATING AT LOW POWER. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552642 ↗
• MalfunctionFeb 19, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT, DURING PROCEDURE, THE CONSOLE WAS NOT EMITTING ENOUGH ENERGY. REPLACING THE FIBER AND THE DEBRIS SHIELD DID NOT RESOLVE THE ISSUE. ANOTHER CONSOLE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391956 ↗
• MalfunctionJan 13, 2026Nonstandard Device; Smoking; Noise, Audible

  IT WAS REPORTED THAT, DURING THE PREPARATION OF THE PROCEDURE, A POPPING SOUND WAS HEARD, AND THE DEVICE FAILED TO TURN ON. UPON INSPECTION, THE BLACK CAP OF THE MAIN TRANSFORMER SHOWED SIGNS OF MELTING, AND A STRONG ODOR WAS DETECTED FROM THE CHARGER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24062553 ↗
• MalfunctionDec 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SPARK CAME OFF FROM FIBER PORT. THE CUSTOMER WAS USING A BROKEN FIBER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828584 ↗
• MalfunctionDec 11, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE UNIT DISPLAYED ERROR 150-FIBER NOT CONNECTED AND ERROR 48-LUMENIS SIS FIBER NOT DETECTED. SUBSEQUENTLY, THE PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779326 ↗
• MalfunctionOct 21, 2025Nonstandard Device; Defective Device; Output below Specifications; Nonstandard Device; Defective Device; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAS LOW POWER OUTPUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351989 ↗
• MalfunctionSep 24, 2025Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem; Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, AN ERROR CODE 188 (COOLING FLOW SWITCH ERROR) OCCURRED. IT WAS NOTED THAT THE PATIENT STAYED IN THE HOSPITAL. THE PATIENT AND PROCEDURE OUTCOME WERE NOT PROVIDED. THIS EVENT IS REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137211 ↗
• MalfunctionJul 12, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER WAS BLOWING THE FIBERS. THE PROCEDURE WAS CANCELLED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487953 ↗
• MalfunctionJun 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CONSOLE'S AIMING BEAM WAS OFF ALIGNMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338303 ↗
• MalfunctionMay 28, 2025Smoking; Smoking

  IT WAS REPORTED THAT WHEN THE DEVICE WAS TURNED ON, A BURNING SMELL WAS OBSERVED. THERE WAS NO REPORT OF PROCEDURE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102346 ↗
• MalfunctionFeb 18, 2025Smoking; Device Displays Incorrect Message; Smoking; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE THE LASER STARTED VISIBLY SMOKING AND EMITTING SMOKE SMELL WHEN STARTED LASING ON THE LAST CASE. ADDITIONALLY, IT DISPLAYED ERROR CODE 265 - LASING AND SAFETY-HOLMIUM CURRENT FAIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS UNDER GENERAL ANESTHESIA, RECOVERED FROM PROCEDURE WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400253 ↗
• MalfunctionDec 30, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LASER WAS NOT PRODUCING ENERGY. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THERE WAS NO REPORT OF PATIENT OUTCOME. 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 21037219 ↗
• MalfunctionDec 16, 2024Device Displays Incorrect Message; Material Integrity Problem; Device Displays Incorrect Message; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LASER DISPLAYED ERRORS 58 AND 142, AND THE FOOT PEDAL WAS NOT WORKING. THE ERRORS WERE UNABLE TO BE CLEARED, SO THE PROCEDURE COULD NOT BE COMPLETED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20944890 ↗
• MalfunctionAug 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE AIMING BEAM WAS UNABLE TO CHANGE, THE LASER TIP WON'T ADJUST AFTER CHANGING SETTINGS. THE PROCEDURE WAS NOT COMPLETED, IT WAS CANCELLED. 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 19975076 ↗
• MalfunctionJul 2, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A CYSTOSCOPY RETROGRADE URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE TO TREAT RENAL CALCULUS, THE CONSOLE DISPLAYED ERROR CODE 224 - SIMMER FAIL ERROR AND IT DID NOT CLEAR. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS UNDER GENERAL ANESTHESIA PRIOR TO CANCELLING THE PROCEDURE. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655982 ↗
• MalfunctionMay 31, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS A BURNING SMELL, THEN IT WAS FOUND THE LASER CORD WAS GETTING REALLY HOT AND IT CAUSED THE LASER TO STOP WORKING. IN ADDITION, WHILE TRYING TO PULL OUT THE CORD, SPARKS WERE NOTICED. THEN, DURING INSPECTION IT WAS FOUND THAT THE WIRES IN THE PLUG WERE VISIBLY BURNT AND, THERE WAS NO DAMAGED FROM THE WALL OUTLET. IT WAS CONFIRMED THAT THE ISSUE WAS WITH THE POWER CORD FROM THE WALL SIDE AND THERE IS NO ISSUE WITH THE CONSOLE. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. 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 19439608 ↗
• MalfunctionMay 30, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE, THE CONSOLE WAS NOT FIRING AND THERE WERE NO ERROR CODES DISPLAYED. IT WAS TRIED TO CHANGE THE FIBER, BUT THE ERROR PERSISTED. THE PROCEDURE WAS NOT COMPLETED, ONLY THE STENT WAS PLACED. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19431135 ↗
• MalfunctionMay 22, 2024Defective Device; Output below Specifications; Noise, Audible; Defective Device; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, A CLICKING SOUND AND LOW POWER WERE IDENTIFIED ON THE CONSOLE. ALSO, THE DEBRIS SHIELD WAS DARKER IN COLOR, THEREFORE IT WAS REPLACED ALONG WITH THE FIBER, BUT THE ISSUE PERSISTED WITH THE CONSOLE. AFTER THAT, THE FIBERS WERE USED WITH A SECOND LASER CONSOLE AND THERE WERE NO ISSUES AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371482 ↗
• MalfunctionApr 19, 2024Device Displays Incorrect Message; Unintended Application Program Shut Down; Device Displays Incorrect Message; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE, THE CONSOLE PROMPTED ERROR 282. THE CUSTOMER TURNED THE LASER OFF, HOWEVER THE LASER COULD NOT BE TURNED BACK ON THEN. AFTER TROUBLESHOOTING, THE BREAKER SWITCH ON THE LASER WAS FOUND TO BE ON THE OFF POSITION AND AFTER, THE LASER WAS TURNED BACK ON. THE PHYSICIAN PUT A STENT IN THE PATIENT AND BROUGHT THE PATIENT BACK AGAIN TO COMPLETE THE PROCEDURE AS THE STONES WERE UNABLE TO BE REMOVED DURING THE FIRST ATTEMPT. THE PATIENT HAD BEEN ADMINISTERED GENERAL ANESTHESIA. THE CUSTOMER IS REQUESTING THAT A FIELD SERVICE ENGINEER(FSE)COME CHECK OUT THE CONSOLE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR WHEN SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141226 ↗
• MalfunctionMar 29, 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 253: "LASING AND SAFETY-PYRO LOW LIMIT FAIL" DISPLAYED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. BOSON 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 WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005615 ↗
• MalfunctionFeb 15, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A BLADDER STONE CYSTOSCOPY, THE DEVICE WAS SHOWING ERROR 87, 269 AND 253. THE WALL OUTLET WAS CHECKED, UNPLUGGED REPLUGGED, RESTARTED, STILL GET ERROR CODES. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE HAD TO BE ABORTED AND THE PATIENT WILL HAVE TO RETURN TO THE OPERATION ROOM AT A LATER DATE TO FINISH THE TREATMENT. 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 18713094 ↗
• MalfunctionJan 2, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A PROCEDURE HAD TO BE CANCELLED DUE TO FOOTSWITCH ISSUES. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED/ABORTED. 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 18432594 ↗