Lumenis Pulse 30HRecalls & reported problems across all models
Lumenis Ltd. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Lumenis Pulse 30H by Lumenis Ltd. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2019 and Aug 11, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Energy” (9 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. 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
Most reported Lumenis Pulse 30H problems
Device problems
- Failure to Deliver Energy9
- Device Displays Incorrect Message8
- Output below Specifications8
- Noise, Audible6
- Defective Device5
- Smoking5
- Nonstandard Device3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Known Impact Or Consequence To Patient5
Lumenis Pulse 30H models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lumenis Pulse 30HPowered Laser Surgical Instrument22 reports
- Lumenis Pulse 30HPowered Laser Surgical Instrument12 reports
- Lumenis Pulse 30HPowered Laser Surgical Instrument10 reports
Recent Lumenis Pulse 30H adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Output below Specifications
It was reported that during a Capital Equipment Service, it was found a decrease in output value due to age-related degradation of the Brick. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202729 ↗MalfunctionJul 30, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093910 ↗MalfunctionMar 30, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT, DURING PROCEDURE AND AFTER SEDATION OF THE PATIENT, THE CONSOLE ISSUED ERROR CODE 4 (FOOTSWITCH FAULT). THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. 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 24714965 ↗MalfunctionMar 16, 2026Output below Specifications
IT WAS REPORTED THAT DURING PREPARATIONS, THE CONSOLE SEEMS TO HAVE LOW POWER. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603889 ↗MalfunctionJan 28, 2026Smoking; Noise, Audible
IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE HAD A LOUD BANG AND A BURNING SMELL. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202421 ↗MalfunctionJan 14, 2026Nonstandard Device; Noise, Audible
IT WAS REPORTED THAT AFTER THE LASER IRRADIATION START, AROUND 20 MINUTES AN UNUSUAL SOUND OCCURS EACH TIME. BURNS WERE CONFIRMED ON THE BLAST SHIELD LENS. IT APPEARED THAT THE CONDENSER LENS BETWEEN THE FIBER PORT AND THE LASER ITSELF HAVE BURNT OUT. THE PROCEDURE WAS DISCONTINUED. THE FIBER, BLAST SHIELD AND THE CONDENSER LENS WERE REPLACED. ON THE NEXT DAY THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT BEING SEDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24071393 ↗MalfunctionDec 29, 2025Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible
IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE TO CRUSH KIDNEY STONES, THE CONSOLE MADE AN UNUSUAL NOISE, AND THERE WERE NO MORE LASER SHOTS BEING FIRED. THE PHYSICIAN WAS UNABLE TO COMPLETE THE LITHOTRIPSY AND DECIDED TO PLACE A URETERAL STENT AND THE PROCEDURE WILL BE COMPLETED ANOTHER TIME. 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 23908591 ↗MalfunctionDec 23, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING PREPARATION POST-SEDATION, THE CONSOLE DISPLAYED ERROR CODES 49 PYRO MAIN NOT EQUAL TO PYRO SAFE AND ERROR CODE 54 SW AUTOCAL FAULT: N=1 / NOT DONE: N=2. THE PROCEDURE WAS DISCONTINUED DUE TO DEVICE DEFECT. 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 23880421 ↗MalfunctionDec 10, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT THE DEVICE'S LASER OUTPUT WAS DECREASING. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23774355 ↗MalfunctionOct 29, 2025Smoking; Noise, Audible; Smoking; Noise, Audible
IT WAS REPORTED THAT A LOUD NOISE WAS HEARD FROM THE DEVICE, FOLLOWED BY SMOKE FROM THE REAR PART. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23420548 ↗MalfunctionSep 26, 2025Nonstandard Device; Output below Specifications; Nonstandard Device; Output below Specifications
IT WAS REPORTED THAT THE ENERGY OUTPUT OF THIS DEVICE WAS TOO LOW. THERE WERE NO REPORT OF PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23159478 ↗MalfunctionSep 24, 2025Smoking; Output below Specifications; Noise, Audible; Smoking; Output below Specifications; Noise, Audible
IT WAS REPORTED THAT THERE WAS SMELL AND VIBRATIONS FROM CONSOLE. ALSO, THERE WAS A STRANGE NOISE AND LOW POWER WITHIN THE CONSOLE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23133499 ↗MalfunctionSep 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PROCEDURE, THE FOOT PEDAL OF THIS DEVICE WAS STUCKED AND PROMPTED AN ERROR CODE 7 (FOOTSWITCH PRESSED (DURING SELF-TEST & ENTER READY) - RELEASE THE FOOTSWITCH). THERE WERE NO REPORTS OF PATIENT OR PROCEDURE OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23100061 ↗MalfunctionAug 25, 2025Output below Specifications; Output below Specifications
IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE WAS NOT GETTING ENOUGH POWER AND THERE IS AN AIMING BEAM ISSUE RELATED TO ITS LIGHT BRIGHTNESS. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22884544 ↗MalfunctionApr 7, 2025Smoking; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Smoking; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING THE INSTALLATION OF THIS SYSTEM, THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE DEVICE EXPLODED AND STARTED TO SMOKE FROM THE CHARGER LOCATION. ERROR 25 (CHARGER FAULT) WAS ALSO DISPLAYED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21793460 ↗
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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