Lumenis Pulse 120H (REF GA-0008800)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07290109145419), received between Feb 20, 2023 and Aug 20, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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, 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 30, 2026Smoking; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PREPARATION AND PRIOR TO PROCEDURE, A BURNING SMELL WAS NOTICED, AND THE CONSOLE TURNED OFF BY ITSELF. THERE WAS NO REPORT OF PATIENT AND PROCEDURE OUTCOME PROVIDED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PATIENT AND PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673569 ↗
• MalfunctionMay 18, 2026Smoking

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE EMITTED A LOUD BANG, AFTER WHICH THE FIBERS OF THE LASER PROBE BEGAN TO SMOLDER, PRODUCING SMOKE. THE USER REPLACED THE PRISM AND CONNECTED A NEW LASER PROBE; HOWEVER, THE FIBERS OF THIS SECOND PROBE ALSO BEGAN TO SMOLDER, WITH INCREASED SEVERITY. THE DEVICE HAD SUCCESSFULLY COMPLETED ITS SELF TEST PRIOR TO USE, WITH NO ISSUES IDENTIFIED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OR PROCEDURE OUTCOME, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210905 ↗
• MalfunctionFeb 4, 2026Failure to Power Up

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE CONSOLE SYSTEM DID NOT START. THE PATIENT WAS ON THE TABLE WAITING WHEN THE DEVICE ISSUE OCCURRED. IT WAS NOTED THAT THE POWER SOCKET, ON OFF SWITCH, KEY, AND EMERGENCY BUTTON WERE ALL CHECKED AND FOUND TO BE FUNCTIONING PROPERLY. AS A RESULT, IT WAS DETERMINED THE CONSOLE NEEDED TO BE CHECKED. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS. 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 24259402 ↗
• MalfunctionJan 8, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, PRIOR TO THE PROCEDURE, THE DEVICE DISPLAYED ERROR CODE 58: (SELF-TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH A FAIL STATUS)) AND THE MESSAGE CHANGE FOOTSWITCH. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007852 ↗
• MalfunctionAug 18, 2025Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Output below Specifications; Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT THIS DEVICE PROMPTED AN ERROR CODE 240 (SYSTEM NOT CALIBRATED), 78 (CALIBRATION INTERRUPTED IN THE MIDDLE), 252 (LASING AND SAFETY-PYRO MAIN NOT EQUAL PYRO SAFE) AND CASE SAVER AFTER REPAIR AND PREVENTATIVE MAINTENANCE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835376 ↗
• MalfunctionAug 8, 2025Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem; Nonstandard Device; Device Displays Incorrect Message; Communication or Transmission Problem

  IT WAS REPORTED THAT ERROR 48 DISPLAYED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. 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 22750005 ↗
• MalfunctionApr 17, 2025Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE SHOWED AN ERROR CODE 200 (COOLING SYSTEM ERROR- CHILLER TEST FAIL), ERROR CODE 190 (CHILLER BUSY ON), AND ERROR CODE 185 (COOLING SYSTEM ERROR-AMBIENT TEMP GREATER THAN 40 DEGREES CELSIUS). 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 IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857919 ↗
• MalfunctionMar 24, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS SMOKE SMELL DEVELOPMENT COMING FROM THE DEBRIS SHIELD. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677027 ↗
• MalfunctionDec 18, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SYSTEM DID NOT START. THE PROCEDURE COULD NOT BE COMPLETED. 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 20965809 ↗
• MalfunctionDec 13, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE DEBRIS SHIELDS, AND THREE FIBERS WERE BURNED. THE PROCEDURE WAS NOT COMPLETED. 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 ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926009 ↗
• MalfunctionNov 12, 2024Smoking; Defective Device; Smoking; Defective Device

  IT WAS REPORTED THAT THE CONSOLE ALIGNMENT IS OFF AND THERE IS A BURNING SMELL AT FIRST USE AFTER REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669283 ↗
• MalfunctionJul 3, 2024Output below Specifications; Noise, Audible; Output below Specifications; Noise, Audible

  IT WAS REPORTED THAT, THE AIMING BEAM IS FADED, AND THE AIMING BEAM OUTPUT IS LOW. IN ADDITION, THERE IS NOISE WHEN TURNED ON. THE CONSOLE IS STILL FUNCTIONAL, AND NO ERROR MESSAGE IS GIVEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666632 ↗
• MalfunctionApr 17, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, THE CONSOLE DISPLAYED ERROR CODES 270 (SYSTEM NOT OPERATIONAL FOR TREATMENT. TO OPERATE THE SYSTEM, TURN THE KEY SWITCH ON, AND RESTART SYSTEM) AND 58 (SELF-TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH FAIL STATUS). THERE WERE NO PATIENT COMPLICATIONS, HOWEVER THE PROCEDURE COULD NOT START DUE TO THIS EVENT. 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 19125490 ↗
• MalfunctionJan 7, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT ERRORS 58 (SELF TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH FAIL STATUS)), 203 (CHARGER ERROR-CHARGER FAIL (FAILED CHARGING WITHIN TIMEOUT 300 MS)), AND 208 (CHARGER ERROR-CHARGER TEST FAIL) OCCURRED PRIOR TO THE PROCEDURE. INFORMATION REGARDING WHETHER THE PATIENT HAD BEEN SEDATED WAS NOT AVAILABLE. THE PROCEDURE WAS THEN CANCELLED. 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 18461404 ↗
• MalfunctionFeb 20, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING PROCEDURE, THE ERROR CODES 198, 189, 183 AND 202 WERE OBSERVED. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405995 ↗