Lumenis Pulse 60H Lumenis Pulse 60H, 50HzRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290109144665), received between May 4, 2023 and Sep 18, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Power Up; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820857 ↗
• MalfunctionAug 8, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE CONSOLE IS NOT TURNING ON, THERE IS NO SOUND INSIDE. THIS CASE WAS NOT COMPLETED, AND THE PATIENT WAS WOKEN UP FROM ANESTHESIA. 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 22749216 ↗
• MalfunctionFeb 28, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PREPARATION, THE CONSOLE SHOWED AN ERROR CODE 240 (HO SYSTEM NOT CALIBRATED - DETECTED IN USER MODE ON STARTUP THAT SYSTEM NOT CALIBRATED BY SERVICE/MANUFACTURING BEFORE) AND 268 (LASING AND SAFETY-MMCU SW DETECTED TIMEOUT ON DELIVERING FIRST PULSE). THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, HOWEVER, A PLANNED PROCEDURE ON (B)(6) 2025, WAS PERFORMED, AND WAS COMPLETED WITH ANOTHER DEVICE. 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 21493694 ↗
• MalfunctionDec 3, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A FLEXIBLE URETEROSCOPY PROCEDURE, IT WAS ATTEMPTED TO PLUG THE FIBER INTO THE LASER CONNECTION PORT, BUT IT WOULD NOT CONNECT AND, THERE WAS RESISTANCE. THE FIBER BROKE WHILE TRYING TO DISCONNECT IT. FURTHER FIBERS WERE OPENED AND ATTEMPTED TO CONNECT BEFORE DETERMINING THAT IT WAS A CONSOLE ISSUE WITH THE CONNECTION PORT. THE PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836397 ↗
• MalfunctionNov 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE DURING PROCEDURE THE FIBER GOT STUCK, AFTER ATTEMPTING MULTIPLE TIMES THE FIBER WAS REMOVED. DIFFERENT FIBERS WERE TRIED, BUT NONE COULD BE INSERTED IN THE CONSOLE WITHOUT FEELING THAT FORCE WOULD HAVE TO BE USED, WITH THE RISK OF THE FIBER GETTING STUCK AGAIN. A NEW FIBER FOCUS ASSEMBLY SPARE PART WILL BE SENT. THE PROCEDURE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728952 ↗
• MalfunctionNov 1, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER FAILED TO POWER UP DURING THE STARTUP SEQUENCE, THE SYSTEM WAS ATTEMPTED TO RESTART SEVERAL TIMES. THE PROCEDURE WAS CANCELLED WHEN THE PATIENT WAS UNDER GENERAL ANESTHESIA ON THE OPERATION TABLE. 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 20587386 ↗
• MalfunctionApr 5, 2024Device Displays Incorrect Message; Power Problem; Device Displays Incorrect Message; Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN SEDATED USING GENERAL ANESTHESIA IN PREPARATION FOR THE PROCEDURE WHICH WAS GOING TO OCCUR IN THE KIDNEY. DURING THE PROCEDURE, THE CONSOLE STOPPED WORKING. THE SCREEN ON THE CONSOLE TURNED LIGHT BLUE WITHOUT ANY WRITING ON IT. THEN, A MESSAGE APPEARED ON THE SCREEN. THE CONSOLE WAS RESTARTED IN ACCORDANCE WITH THE INSTRUCTIONS ON THE SCREEN. AFTER A SHORT PERIOD OF USE, THE SAME DEVICE ISSUE OCCURRED. THE PHYSICIAN THEN DECIDED TO TURN THE CONSOLE OFF AND NOT USE IT ANYMORE. AS A RESULT, THE SURGEON WAS UNABLE TO USE AS MUCH LASER AS SHE WOULD HAVE DESIRED FOR THE PATIENT. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050088 ↗
• MalfunctionMay 4, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE DEBRIS SHIELD WAS MOVING A LOT AND THE CONSOLE DID NOT DETECT IT; DUE TO THIS, THE LASER STOPPED WORKING AND THE SURGERY WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873705 ↗