SPLENDOR X ALEX + Nd:YAG APMD122.SPXRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08052049500067), received between Jul 8, 2020 and Sep 14, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Lumenis received an adverse event report on a patient who sustained injury following treatment by SPX device.

  Patient problems: Insufficient Information

  MAUDE report 50751870 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  BIOS RECEIVED FROM THE IMPORTER LUMENIS ON ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED SHOCK FOLLOWING TREATMENT BY SPX DEVICE. CUSTOMER ADVISED THAT A DEEP SHOCK TO THE HEAD WAS FELT WHEN CUSTOMERS HAIR BRUSHED THE FIBER. HOWEVER, SINCE THE CUSTOMER DIDN'T SENT US EVEN ONE INCIDENT FORM AND NO PHOTO, WE TREAT THIS CASE AS A SINGLE ISSUE IN CURRENT COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 24996556 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED ON ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED SHOCK FOLLOWING TREATMENT BY SPX DEVICE. CUSTOMER ADVISED THAT A DEEP SHOCK TO THE HEAD WAS FELT WHEN CUSTOMERS HAIR BRUSHED THE FIBER. HOWEVER, SINCE THE CUSTOMER DIDN'T SENT US EVEN ONE INCIDENT FORM AND NO PHOTO, WE TREAT THIS CASE AS A SINGLE ISSUE IN CURRENT COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 24994455 ↗
• InjuryApr 24, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  BIOS, RECEIVED FROM THE IMPORTER LUMENIS AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE

  Patient problems: Burn(s)

  MAUDE report 24976065 ↗
• InjuryApr 23, 2026Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE.

  Patient problems: Burn(s)

  MAUDE report 24966351 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT BY CE DURING SERVICE VISIT IN THE CLINIC. THE ADVERSE EVENT WAS CAUSED DURING MODEL TESTING THAT HAS BEEN BURNED FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

  Patient problems: Burn(s)

  MAUDE report 24660887 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24005641 ↗
• InjuryDec 3, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  BIOS RECEIVED FROM ITS IMPORTER LUMENIS AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

  Patient problems: Burn(s)

  MAUDE report 23704491 ↗
• InjuryNov 30, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

  Patient problems: Burn(s)

  MAUDE report 23677003 ↗
• InjuryNov 5, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  BIOS RECEIVED FROM THE IMPORTER LUMENIS AN ADVERSE EVENT REPORT ON PATIENT WHO SUSTAINED BURN AT THE LEGS AREA FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

  Patient problems: Burn(s)

  MAUDE report 23474100 ↗
• InjuryNov 5, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON PATIENT WHO SUSTAINED BURN AT THE AXILLA AREA FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

  Patient problems: Burn(s)

  MAUDE report 23473734 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Burn(s)

  MAUDE report 23356456 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Burn(s)

  MAUDE report 22768679 ↗
• InjuryJun 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  LUMENIS, THE BIOS S.R.L. DISTRIBUTOR, RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22209497 ↗
• InjuryJun 13, 2025Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

  (B)(4), THE BIOS S.R.L. DISTRIBUTOR, RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BLISTER AND SCAR AT THE FACE AREA FOLLOWING TREATMENT BY SPLENDOR X DEVICE. TWO INCIDENT FORMS HAVE BEEN RECEIVED IN (B)(4). THIS COMPLAINT WILL HANDLE PATIENT 1 OUT OF 2 WITH INITIALS- (B)(6).

  Patient problems: Scar Tissue

  MAUDE report 22203338 ↗
• InjuryJun 9, 2025Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BLISTER AND SCAR AT THE FACE AREA FOLLOWING TREATMENT BY SPLENDOR X DEVICE. TWO INCIDENT FORMS HAVE BEEN RECEIVED IN LUMENIS. THIS COMPLAINT WILL HANDLE PATIENT 2 OUT OF 2 WITH INITIALS - (B)(6).

  Patient problems: Scar Tissue

  MAUDE report 22165772 ↗
• InjuryJun 9, 2025Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BLISTER AND SCAR AT THE FACE AREA FOLLOWING TREATMENT BY SPLENDOR X DEVICE. TWO INCIDENT FORMS HAVE BEEN RECEIVED IN LUMENIS. THIS COMPLAINT WILL HANDLE PATIENT 1 OUT OF 2 WITH INITIALS - (B)(6).

  Patient problems: Scar Tissue

  MAUDE report 22165753 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Burn(s)

  MAUDE report 22164988 ↗
• InjuryAug 23, 2024Missing Information; Missing Information

  ON AUGUST 9TH 2024 LUMENIS (MR. (B)(6) REPORTS (VERBATIM): "I'M INFORMING YOU THAT WE GOT A NEW SAFETY (B)(4). THE PATIENT REPORTED ON INJURY (BLISTERS AFTER TREATMENT) USING GA-5000000: (B)(6). THERE IS NO ALLEGATION ON MALFUNCTION. THE DEVICE IS ON WARRANTY. WE'RE WAITING FOR CLINICAL EVALUATION AND TESTING/SERVICE. CURRENTLY, OUR CLINICAL EXPERT IS IN TOUCH WITH THE CUSTOMER." INCIDENT FORM IS COMPILED, HANDWRITTEN AND PHOTOGRAPHED. PICTURES OF FORM ATTACHED TO THE COMPLAINT NOTIFICATION MAIL. THE FOLLOWING INFORMATION ARE RETRIEVED: TEST SPOT NOT DONE. TIP SIZE 5 MM, SQUARE, 25 MS PULSE. SMOKE EVACUATOR 5 OF 5, COOLING OFF FOR FIRST 4 PASSES. HAIR LIGHT BROWN AND FINE, NO PICTURE AVAILABLE. PATIENT: INITIALS C.S., NO SESSIONS BEFORE THIS, FEMALE, LIGHT SKIN. NO CONTRAINDICATIONS KNOWN. SEVERE EVENT. EVENT: BURN, BLISTERING, INTENSE/ABNORMAL PAIN. REQUIRED MEDICAL INTERVENTION: PATIENT WENT TO THEIR DERMATOLOGIST; PERMANENT EFFECTS NOT KNOWN. PROBLEM DESCRIPTION (AS REPORTED): "SEE E-MAIL FOR FULL DESCRIPTION. CLIENT BURNED BY LUMENIS TRAINER DURING ROSACEA TREATMENT. COOLING WAS NOT APPLIED TO FIRST FOUR PASSES" ON AUGUST 9TH, 2024 BIOS (MR. (B)(6) ASKED TO LUMENIS (MS. (B)(6):

  Patient problems: Burn(s)

  MAUDE report 20046995 ↗
• InjuryAug 15, 2024Missing Information; Missing Information

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Burn(s)

  MAUDE report 19989743 ↗
• InjuryAug 5, 2024Missing Information; Missing Information

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 19904004 ↗
• InjuryMar 14, 2024Device Handling Problem; Device Handling Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON 4 PATIENTS WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE. SINCE THE CUSTOMER DIDN'T PROVIDE EVEN ONE INCIDENT FORM, THESE CASES WERE TREATED IN ONE SINGLE COMPLAINT.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 18901503 ↗
• InjuryDec 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X DEVICE.

  Patient problems: Burn(s)

  MAUDE report 18341761 ↗
• InjuryNov 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BLISTER FOLLOWING TREATMENT BY SPLENDOR X DEVICE.

  Patient problems: Burn(s)

  MAUDE report 18207670 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 18099415 ↗