Lumenis Pulse 120HRecalls & reported problems across all models
Lumenis Ltd. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Lumenis Pulse 120H model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 440
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 1
We found 12 models of Lumenis Pulse 120H by Lumenis Ltd. in the FDA's device registry (GUDID). Together they are named in 440 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2019 and Sep 28, 2026 — classified as 21 injuries, 419 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (116 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Lumenis Pulse 120H recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
Most reported Lumenis Pulse 120H problems
Device problems
- Device Displays Incorrect Message116
- Output below Specifications94
- Defective Device58
- Smoking55
- Adverse Event Without Identified Device or Use Problem51
- Nonstandard Device41
- Failure to Deliver Energy36
- Noise, Audible35
Patient problems
- No Clinical Signs, Symptoms or Conditions373
- No Known Impact Or Consequence To Patient45
- Burn(s)5
- Hematuria4
- Hemorrhage/Blood Loss/Bleeding4
- No Consequences Or Impact To Patient4
- Perforation2
- Stenosis2
Lumenis Pulse 120H models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lumenis Pulse 120H Lumenis Pulse Moses 2.0 (DOM)Powered Laser Surgical Instrument1 recall161 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument102 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument1 recall34 reports
- Lumenis Pulse 120H Lumenis Pulse P120 30 AmpPowered Laser Surgical Instrument1 recall22 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument40 reports
- Lumenis Pulse 120H Lumenis Pulse Moses 2.0(INT)Powered Laser Surgical Instrument21 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument21 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument16 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument14 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument6 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument2 reports
- Lumenis Pulse 120HPowered Laser Surgical Instrument1 report
Recent Lumenis Pulse 120H adverse event reports
The 15 most recent reports across all models, 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 21, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847389 ↗MalfunctionSep 18, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820308 ↗MalfunctionSep 17, 2026Nonstandard Device; Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812423 ↗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 ↗MalfunctionSep 16, 2026Material Integrity Problem
It was reported that during procedure, the device malfunctioned. 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 50788914 ↗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 ↗MalfunctionAug 20, 2026Nonstandard Device; Output below Specifications
It was reported that during procedure, the console had several fibers and a blast shield burnt. Additionally, the console had a low energy issue. The procedure was completed without patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354631 ↗MalfunctionAug 19, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331342 ↗MalfunctionAug 18, 2026Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304666 ↗MalfunctionAug 7, 2026Nonstandard Device
It was reported that during a holmium laser enucleation of the prostate to treat benign prostatic hyperplasia, the console's blast shield sustained consecutive burn damage. There were no patient complications. However, the procedure was cancelled with the patient already under anesthesia.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 50180359 ↗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 ↗
Other Lumenis Ltd. products
All Lumenis Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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