Lumenis Pulse 120H (REF GA-2003477)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07290109145440), received between Feb 24, 2023 and Sep 17, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Nonstandard Device; Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812423 ↗
• MalfunctionAug 18, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304666 ↗
• MalfunctionMay 15, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE SEEMED TO HAVE LOW OUTPUT. THERE IS NO INFORMATION ABOUT PATIENT AND PROCEDURE OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191459 ↗
• MalfunctionMar 2, 2026Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING PROCEDURE THE OUTPUT WAS WEAK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491392 ↗
• MalfunctionJan 13, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEBRIS SHIELD BURNED OUT TWICE, LEADING TO THE CANCELLATION OF THE PROCEDURE. 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 24060640 ↗
• MalfunctionSep 12, 2025Poor Quality Image; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Poor Quality Image; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED DURING PROCEDURE, WHEN LASER IRRADIATION WAS ATTEMPTED, A NOISE WAS HEARD AFTER THE DOTTED LINE WAS DISPLAYED. THE DEBRIS SHIELD AND FIBER WERE REPLACED, HOWEVER, THERE WAS NO IMPROVEMENT. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS CONFIRMED THAT THE ISSUE WAS PRIMARILY DUE TO THE CONSOLE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039060 ↗
• InjuryMay 1, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING LITHOTRIPSY PROCEDURE, THE CONSOLE DISPLAYED ERRORS 188: "COOLING FLOW SWITCH ERROR" AND 55: "COMMUNICATION PROTOCOL ERROR". THE LASER COULD NOT BE USED, AND A URETERAL STENT WAS PLACED. THE PROCEDURE HAD TO BE CANCELLED/RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS. 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 21947308 ↗
• MalfunctionOct 30, 2024Adverse Event Without Identified Device or Use Problem; Output below Specifications; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE WAS IN LOW OUTPUT MODE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570810 ↗
• MalfunctionNov 16, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED ERROR CODES 48 (SIS-FIBER IS NOT LUMENIS FIBER (OR NO SIS DETECTED)), 58 (SELF-TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH FAIL STATUS)), 150 (LASER DECK - FIBER NOT CONNECTED) AND 188(COOLING SYSTEM ERROR-COOLING FLOW SWITCH ERROR). THE CONSOLE WAS REBOOTED BUT IT DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED. 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 18155011 ↗
• MalfunctionNov 16, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE CONSOLE DISPLAYED ERROR CODES 48 (SIS-FIBER IS NOT LUMENIS FIBER (OR NO SIS DETECTED)), 58 (SELF-TEST PROCESS FAILURE (ONE OF THE TESTS COMPLETED WITH FAIL STATUS)), 150 (LASER DECK - FIBER NOT CONNECTED) AND 188 (COOLING SYSTEM ERROR-COOLING FLOW SWITCH ERROR). THE CONSOLE WAS REBOOTED BUT IT DID NOT RESOLVE THE ISSUE, AND THE PROCEDURE WAS CANCELLED. 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 18154900 ↗
• MalfunctionNov 8, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE OUTPUT IS LOW. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097746 ↗
• MalfunctionOct 10, 2023Defective Device; Output below Specifications; Defective Device; Output below Specifications

  IT WAS REPORTED THAT THE BLAST SHIELD LENS WAS BURNT DURING THE PROCEDURE AND THE BLAST SHIELD LENS AND PROBE WERE REPLACED BUT THE OUTPUT SEEMS WEAK. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909371 ↗
• MalfunctionSep 25, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE TO ENLARGED PROSTATE, THE CONSOLE PRESENTED LOW POWER MODE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE, WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808129 ↗
• MalfunctionFeb 24, 2023Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, BUT AFTER THE PATIENT HAD BEEN SEDATED, THE CONSOLE WENT INTO LOW POWER MODE. THE PROCEDURE WAS CANCELLED DUE TO THE DEVICE ISSUES. 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 16435139 ↗