Lumenis Pulse 120H (REF GA-0008700)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07290109145464), received between Aug 31, 2022 and Aug 19, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (14 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 16, 2026.

Recalls naming this device

1. Jan 23, 2025Open, 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331342 ↗
• MalfunctionJul 31, 2026Nonstandard Device; Output below Specifications

  It was reported that during procedure, the console had the issue burning the blast shield and fibers, and the laser power was decrease. The procedure was completed with this console without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100126 ↗
• MalfunctionJul 21, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893318 ↗
• MalfunctionApr 10, 2026Complete Loss of Power

  IT WAS REPORTED THAT THERE WAS NO ENERGY OUTPUT. THERE WERE NO ERRORS. THE FIBER AND BLAST SHIELD ALREADY HAD BEEN CHANGED. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE WAS CANCELLED. 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 24839024 ↗
• MalfunctionApr 7, 2026Overheating of Device; Smoking

  IT WAS REPORTED THAT THE CONSOLE STARTED TO OVERHEAT AND BURN OUT. A BURNING SMELL WAS ALSO COMING FROM THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809079 ↗
• MalfunctionMar 25, 2026Nonstandard Device; Communication or Transmission Problem; Material Integrity Problem

  IT WAS REPORTED THAT ERRORS 138: "EXTERNAL INDICATOR - EMERGENCY STOP STATUS FAIL" AND 58: "SELF TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH FAIL STATUS)" DISPLAYED. THE LASER CONTINUED TO INDICATE COMPUTER WISE AS IF ENERGY WAS BEING GIVEN. THE PEDAL WAS NOT PRESSED THEN. THE EMERGENCY STOP BUTTON WAS PRESSED BUT IT DID NOT RESPOND. AT THE END, THE CONSOLE WAS FORCED TO TURN OFF WITH THE ON/OFF BUTTON. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694005 ↗
• MalfunctionFeb 16, 2026Smoking

  IT WAS REPORTED THAT DURING PREPARATION A BURNING PLASTIC SMELL WHEN TURNING ON THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24354990 ↗
• MalfunctionJan 30, 2026Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD INSUFFICIENT POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222700 ↗
• MalfunctionDec 1, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE DEVICE'S DEBRIS SHIELD AND FIBERS WERE BURNING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. 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 23685762 ↗
• MalfunctionSep 23, 2025Nonstandard Device; Output below Specifications; Noise, Audible; Nonstandard Device; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE PRESENTED ODD RATTLING NOISE WHEN TRYING TO USE AND A LOW POWER OUTPUT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23127284 ↗
• MalfunctionAug 19, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS SMOKE COMING OUT OF THE LASER. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE INFORMATION ABOUT THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845642 ↗
• MalfunctionMay 27, 2025Device Displays Incorrect Message; Output below Specifications; Device Displays Incorrect Message; Output below Specifications

  IT WAS REPORTED THAT THE DEVICE SETTING WOULD NOT GO HIGHER THAN 60 HERTZ 72 WATTS. IT WAS NOTED THAT ERROR CODES 46 (FIBER EXPIRATION DATE ERROR), AND ERROR CODE 50 (FIBER HAS REACHED MAXIMUM ENERGY) WAS PROMPTED. THERE WAS NO REPORT OF PROCEDURE OR PATIENT INVOLVED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, THE PATIENT, AND THE PROCEDURE OUTCOME, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090577 ↗
• MalfunctionApr 27, 2025Defective Device; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Defective Device; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, A FIBER WAS CONNECTED TO THE CONSOLE, AND CRACKING AND SPARKING NOISES CAME FROM THE CONSOLE. THE CONSOLE PROMPTED ERROR CODE 162 (LASER DECK-SPARE BLAST SHIELD), SO THE BURNED DEBRIS SHIELD WAS REPLACED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THIS OCCURRENCE HAPPENED IN TWO DIFFERENT PROCEDURES. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN. THIS EVENT IS FOR THE SECOND ABORTED/PROCEDURE CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916047 ↗
• MalfunctionMar 26, 2025Smoking; Defective Device; Noise, Audible; Smoking; Defective Device; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE HAD AN ENERGY OUTPUT FAILURE. IN ADDITION, THE CONSOLE HAD CRACKLING NOISES AND SMOKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704232 ↗
• MalfunctionMar 26, 2025Smoking; Defective Device; Noise, Audible; Smoking; Defective Device; Noise, Audible

  IT WAS REPORTED THAT THE CONSOLE WAS SMOKING AND ALSO PRESENTED WITH ENERGY DELIVERY FAILURE, BURNT SPOTS, AND A BLOW DEBRIS SHIELD. ADDITIONALLY, THE FIBER HAD VISIBLE SPARKS WHICH IS INDICATIVE OF A FIBER BREAK. AN ORANGE AND RED RING WAS NOTED AROUND THE FIBER FOLLOWED BY AN UNPLEASANT CRACKLING NOISE BEFORE THE FIBER STOPPED WORKING ALTOGETHER. THERE WAS NO FURTHER INFORMATION PROVIDED ON THE PROCEDURE OR PATIENT OUTCOME. THIS REPORT IS FOR THE CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701625 ↗
• MalfunctionMar 14, 2025Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERROR 142 (EXTERNAL INDICATOR - FOOT SWITCH SW1 STATUS FAIL), 143 (EXTERNAL INDICATOR - FOOT SWITCH SW2 STATUS FAIL) AND 58 (SELF TEST PROCESS FAILURE) WERE DISPLAYED. THE PATIENT CAME FOR INTRAVESICAL LITHOTRIPSY AND HOLMIUM LASER PROSTATE ENUCLEATION. DUE TO THE PEDAL PROBLEM, THE PHYSICIAN PERFORMED THE INTRAVESICAL LITHOTRIPSY WITH ANOTHER LASER, BUT DID NOT PERFORM THE PROSTATIC ENUCLEATION. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606400 ↗
• MalfunctionMar 13, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN THE LASER WAS TURNED ON THERE WAS SMOKE SMELL COMING OUT OF THE MACHINE, SO THE STAFF HAD TO SWITCH IT OFF AND USE THE LOAN MACHINE INSTEAD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596394 ↗
• MalfunctionFeb 18, 2025Device 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 66 (BRICK 4 NOT WORKING CASE SAVER MODE) AND ERROR 150 (FIBER NOT CONNECTED) WERE DISPLAYED. THE PROCEDURE WAS CANCELLED BECAUSE IT WAS A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) CASE WHICH REQUIRES HIGHER POWER. THERE WAS NO PATIENT OUTCOME REPORTED. 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 21403756 ↗
• MalfunctionFeb 11, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, FOUR FIBERS WERE BURNED. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS TREATED WITH ANOTHER DEVICE PARTIALLY. THERE WERE NO PATIENT COMPLICATIONS. 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 21360446 ↗
• MalfunctionDec 30, 2024Failure to Power Up; Defective Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Defective Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN EMERGENCY PROCEDURE, THE DISPLAY SCREEN REMAINED BLACK. THE PROCEDURE WAS NOT COMPLETED. 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 21044519 ↗
• MalfunctionDec 17, 2024Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Power Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Power Problem

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE CONSOLE STOPPED WORKING AND DISPLAYED THE ERROR CODES: 258 (LASING AND SAFETY-PULSE RATE HIGH), 223 (SWM AND SAFETY IGBT-SWM2 SIMMER FAIL), 216 (SWM AND SAFETY IGBT-SAFETY IGBT LEAKAGE FAIL) AND 283 (SAFETY OK H/W LINE FAIL). THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE CASE WAS NOT COMPLETED DUE TO THE EVENT WITH THE CONSOLE. 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 20956384 ↗
• MalfunctionDec 16, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE, ERROR 273 (SAFETY OK H/W LINE FAIL) AND 253 (LASING AND SAFETY-PYRO LOW LIMIT FAIL) WERE DISPLAYED BY THE CONSOLE. THE DEVICE COULD NOT BE USED IN THE PROCEDURE AND THEREFORE THE PROCEDURE WAS CANCELLED/RESCHEDULED. 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 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 20947507 ↗
• MalfunctionOct 14, 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 PRIOR THE PROCEDURE, THE CONSOLE DISPLAYED ERRORS 58 (SELF-TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH FAIL STATUS)), 188 (COOLING SYSTEM ERROR-COOLING FLOW SWITCH ERROR) AND 200 (COOLING SYSTEM ERROR- CHILLER TEST FAIL). DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440819 ↗
• MalfunctionJun 4, 2024Defective Device; Noise, Audible; Defective Device; Noise, Audible

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE LASER CONSOLE MADE A STRANGE NOISE, AND THE DEBRIS SHIELD WAS FOUND TO BE BROKEN. THE DEBRIS SHIELD AND THE LASER FIBER WERE REPLACED, HOWEVER, THE NOISE STILL REMAINED. THE DEVICE WAS UNABLE TO BE USED AND THE PROCEDURE WAS RESCHEDULED. THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS 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 19456227 ↗
• MalfunctionApr 23, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, WITH A PATIENT ON THE TABLE, TWO FIBERS FROM ONE LOT AND ONE MORE FIBER FROM ANOTHER LOT FAILED TO BE RECOGNIZED BY THE CONSOLE. IT WAS NOTED THAT THE CONSOLE ISSUED ERROR CODE 150 (LASER DECK - FIBER NOT CONNECTED), WHICH MEANS THE FIBER WIRES WERE NOT CONNECTED TO THE CONSOLE. THE MEDICAL STAFF HAD ALREADY TURNED THE LASER OFF AND ON, CHECKED THE PLUGS, CHECKED THE "GLASS", BUT THE LASER CONTINUED TO GIVE ERROR CODE 150 EVEN WITH A NEW FIBER OF THE SAME LOT NUMBER. THE PROCEDURE HAD TO BE STOPPED. 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 19166499 ↗