Lumenis Pulse 120H Lumenis Pulse Moses 2.0 (DOM)Recalls & reported problems
Lumenis Ltd. · Class 2
All models of Lumenis Pulse 120H (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Lumenis Pulse 120H is a powered laser surgical instrument. Of its 172 reports, 8 are filed as injuries, and many describe incorrect warning messages, weak laser output, burning smells, and rattling or ticking noises. The reports mention no deaths. The laser has 1 open recall, from January 2025, over chargers whose start-up current can overheat parts so the laser does not power on.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 07290109145525), received between Aug 19, 2022 and Sep 28, 2026 — classified as 5 injuries, 156 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (61 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Device Displays Incorrect Message61
- Output below Specifications40
- Smoking25
- Adverse Event Without Identified Device or Use Problem23
- Defective Device23
- Noise, Audible18
- Physical Resistance/Sticking15
- Nonstandard Device13
Patient problems
- No Clinical Signs, Symptoms or Conditions156
- Hemorrhage/Blood Loss/Bleeding3
- Hematuria2
- Micturition Urgency1
- Stenosis1
- Urethral Stenosis/Stricture1
- Urinary Incontinence1
Recent adverse event reports
The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925279 ↗MalfunctionSep 24, 2026Smoking; Firing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892135 ↗MalfunctionSep 23, 2026Output below Specifications
It was reported that during procedure, the console was having an issue with the beaming light which was not working and producing a very weak beam. The procedure was completed using the same console. There were no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867426 ↗MalfunctionSep 17, 2026Degraded
It was reported that during procedure, the console kept displaying error code 87 (Brick Lamp Has Aged). The customer requested for a field engineer to repair the laser console. The procedure was aborted. There were no patient complications reported.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797215 ↗MalfunctionAug 24, 2026No Display/Image; Display or Visual Feedback Problem; Communication or Transmission Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420730 ↗MalfunctionAug 21, 2026Optical Problem; Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379215 ↗MalfunctionMay 11, 2026Failure to Power Up; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PROCEDURE, AFTER RELEASING THE FOOT PEDAL THE CONSOLE STILL KEPT FIRING. THE FIBER HAD BEEN SWABBED OUT, AND THE FOOT PEDAL WAS DISCONNECTED AND RECONNECTED, BUT THE ISSUE PERSISTED. LATER, THE CONSOLE WOULD NOT POWER UP WITH THE FOOT PEDAL ATTACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER CONSOLE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144880 ↗MalfunctionApr 15, 2026Smoking
IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE LASER EMITTED A BURNING ODOR DURING ABLATION. THE CASE WAS COMPLETED USING THE ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891612 ↗MalfunctionApr 9, 2026Communication or Transmission Problem
IT WAS REPORTED THAT DURING PREPARATION FOR A URETEROSCOPY PROCEDURE, THE DEVICE DISPLAYED THE ERROR CODES 186 (COOLING SYSTEM ERROR WATER TEMP GREATER THAN 35C, BASED ON TIMEOUT) AND 199 (COOLING SYSTEM ERROR CHILLER FAILED TO REACH 17C 2C WITHIN ABOUT 1.5 MINUTES). THE CASE COULD NOT BE COMPLETED AS IT KEPT ERRORING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825331 ↗MalfunctionApr 7, 2026Display or Visual Feedback Problem; Nonstandard Device; Physical Resistance/Sticking
IT WAS REPORTED THAT THE FOOT PEDAL WAS NOT BEING PRESSED, YET THE LASER WAS OPERATING AS IF IT WERE. WHEN THE STAFF ATTEMPTED TO PLACE THE LASER IN STANDBY MODE, THE SCREEN FROZE. A HARD REBOOT WAS PERFORMED, BUT THE ISSUE PERSISTED. THERE IS NO INFORMATION WHETHER A PROCEDURE WAS PERFORMED, OR IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809072 ↗MalfunctionMar 30, 2026Nonstandard Device; Output below Specifications
IT WAS REPORTED THAT THE CONSOLE WAS WORKING ONLY IN LOW POWER MODE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731710 ↗InjuryMar 30, 2026Failure to Align; Material Integrity Problem; Output below Specifications
IT WAS REPORTED THAT DURING PROCEDURE THIS CONSOLE EXHIBITED LOW POWER WHICH CAUSED THE PATIENT TO HAVE POST BLEEDING. NO ADDITIONAL INFORMATION WAS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24713684 ↗MalfunctionMar 20, 2026Nonstandard Device; Communication or Transmission Problem; Noise, Audible; Unexpected Shutdown
IT WAS REPORTED THAT THE CONSOLE WAS PRODUCING A LOUD NOISE AND EXPERIENCED AN UNEXPECTED SHUTDOWN. THE CONSOLE WAS LATER ABLE TO POWER BACK ON AND DISPLAYED AN UNKNOWN ERROR MESSAGE. ADDITIONALLY, THE EMERGENCY BUTTON FAILED TO OPERATE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24650209 ↗MalfunctionMar 19, 2026Communication or Transmission Problem; Output below Specifications
IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE DISPLAYED ERROR CODE 150 (LASER DECK - FIBER NOT CONNECTED) AND FIBER WAS SWAP OUT TO CLEAR THE ERROR. IT WAS ABLE TO GET THE CONSOLE BACK UP AND RUNNING BUT THERE WAS A LOW POWER EFFICIENCY IN THE CONSOLE. THE PROCEDURE WAS COMPLETED USING THE SAME CONSOLE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641348 ↗MalfunctionMar 12, 2026Communication or Transmission Problem; Output below Specifications
IT WAS REPORTED THAT ERROR 269: "LASING AND SAFETY-WARM-UP FAILED TO GET TO THE THRESHOLD" DISPLAYED. THE CONSOLE IS ALSO STUCK IN LOW POWER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24580309 ↗MalfunctionFeb 25, 2026Communication or Transmission Problem; Output below Specifications; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE CONTINUED LASERING EVEN AFTER THE ACCOUNT STEPPED OFF THE FOOT PEDAL; LATER IT ENTERED IN CASE SAVER MODE. IT ALSO DISPLAYED ERROR CODE 55 (COMMUNICATION PROTOCOL ERROR). NO PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443130 ↗MalfunctionFeb 25, 2026Communication or Transmission Problem
IT WAS REPORTED THAT DURING A CYSTOLITHOLAPAXY PROCEDURE, THE CONSOLE DISPLAYED ERROR CODES 204 - CHARGER ERROR-CHARGER GENERAL FAILURE AND 256 - LASING AND SAFETY-CAPACITORS VOLTAGE FAIL BEFORE PULSE DELIVERED. THE PROCEDURE WAS STOPPED AND RESCHEDULED. THE CASE WAS COMPLETED WITH ORIGINAL DEVICE, AFTER IT WAS FIXED THE NEXT DAY, WITHOUT PATIENT COMPLICATIONS. THE PATIENT WAS UNDER GENERAL ANESTHESIA WHEN THE CASE WAS CANCELLED. 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 24441797 ↗MalfunctionFeb 20, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT THE CONSOLE CONTINUED FIRING DESPITE THE FOOT PEDAL NOT BEING ACTIVATED, REQUIRING THE USE OF THE EMERGENCY STOP BUTTON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403323 ↗MalfunctionFeb 20, 2026Output below Specifications; Physical Resistance/Sticking
IT WAS REPORTED THAT THE DEVICE CONTINUED LASERING EVEN AFTER THE FOOT PEDAL WAS RELEASED. IT WAS ALSO NOTED THAT THE DEVICE WAS IN CASE SAVER MODE. THERE WAS NO REPORT OF PROCEDURE OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401735 ↗MalfunctionFeb 18, 2026Nonstandard Device; Material Integrity Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT THE UNIT WOULD NOT SHUT DOWN. AFTER THE CASE WAS COMPLETED, THE LASER CONTINUED FIRING ON ITS OWN. THE EMERGENCY STOP BUTTON AND THE KEY SWITCH DID NOT RESPOND, AND THE LASER HAD TO BE UNPLUGGED FROM THE OUTLET TO STOP THE EMISSION. NO PATIENT WAS PRESENT AT THE TIME OF THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380578 ↗MalfunctionFeb 18, 2026Fire; Failure to Power Up
IT WAS REPORTED THAT AFTER A COMPONENT REPLACEMENT, THE UNIT WOULD NOT POWER ON CONSISTENTLY AND CONTINUED TO EXHIBIT OPERATIONAL ISSUES. DURING INSPECTION, SIGNS OF BURNED MATERIAL WERE OBSERVED INSIDE THE SYSTEM. ALTHOUGH THE UNIT WAS ABLE TO POWER ON AT TIMES, THE ISSUE PERSISTED. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380538 ↗MalfunctionFeb 12, 2026Smoking
IT WAS REPORTED THAT DURING THE CAPITAL EQUIPMENT INSTALLATION AND THE INITIAL INSPECTION OF THE LASER, IT WAS DISCOVERED THAT THE HARNESS WAS BURNED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328664 ↗MalfunctionFeb 11, 2026Output below Specifications
IT WAS REPORTED THAT THE CONSOLE WAS GETTING LOW POWER OUTPUT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316032 ↗MalfunctionFeb 11, 2026Output below Specifications; Power Problem
IT WAS REPORTED THAT THE LASER WAS LOW ON POWER. IT WAS NOTED THAT THERE WAS AN ENERGY DELIVERY OUTPUT FAILURE. THERE WAS NO REPORT OF PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314528 ↗MalfunctionJan 13, 2026Material Integrity Problem; Output below Specifications
IT WAS REPORTED THAT THIS DEVICE BURNED A FIBER DURING A PROCEDURE AND WAS DETERMINED THAT THE FIBER OPTIC CABLE HAD BEEN BURNED OUT DUE TO MISUSE BY THE USER. THE PROCEDURE WAS COMPLETED WITH LOW POWER INSTEAD. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059946 ↗
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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 · each recall links to the FDA recall notice
- 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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