Spectrum Laser/IPLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00860564000317), received between May 16, 2025 and Jul 27, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026The patient presented to the clinic for a Spectrum IPL training model. "Before" photos were taken prior to the treatment. Numbing cream was applied then removed using gauze and alcohol to prep the skin. Ultrasound gel was used during the treatment. The patient tolerated the treatment well and normal response was noted until the provider treated the left upper cutaneous lip. When this area was treated, the patient immediately said it was very painful and the provider stopped and applied ice/contact cooling. No blistering was noted immediately after treatment, however swelling and redness were noted. Treatment areas were cooled down with ice prior to applying sunscreen before the patient left the office. Patient is a natural Fitzpatrick Skin Type II, however, she did have a notable tan prior to treatment.On (b)(6) 2026 Patient returned to the clinic for a follow-up to assess her face post-treatment after calling the office to inform us that she was dissatisfied with her healing progress. The patient reported pain and swelling and visible blisters were noted on the left cheek as well as the left upper cutaneous lip area. The patient was prescribed topical hydrocortisone

  Patient problems: Scar Tissue

  MAUDE report 50011320 ↗
• InjuryJul 27, 2026Use of Device Problem

  Customer sent pictures of a patient that had an Erbium YAG treatement to the face with well defined areas of demarcation and pronounced erythema. Appearance is consistent with concentrated energy delivery. Rohrer Clinical made several attempts to obtain treatment details without success. It was made known by the provider that initial post care treatment included Neosporin, but switched to vaseline. Provider acknowledged the request for more information but has failed to provide. Rohrer has arranged for additional hand on education and advised to not use the device until this is completed.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50011316 ↗
• MalfunctionApr 27, 2026Electrical /Electronic Property Problem; Unintended Electrical Shock

  USER RECEIVED AN ELECTRICAL SHOCK FROM THE HANDPIECE OF THE SPECTRUM DEVICE AFTER INSTALLING A REPLACEMENT PART. THE USER INSTALLED A REPLACEMENT PART ONTO THE UNIT, MADE CONTACT WITH THE COOLING PLATE ON THE HANDPIECE TO ASSESS WHETHER COOLING WAS FUNCTIONING PROPERLY. UPON CONTACT, THE USER REPORTED EXPERIENCING AN ELECTRICAL SHOCK IN THE HAND, WITH SENSATION TRAVELING UP THE ARM AND INTO THE CHEST. IMMEDIATELY AFTER THE INCIDENT, THE USER REPORTED FEELING LIGHTHEADED AND DIZZY. THE USER PRESENTED TO THE EMERGENCY ROOM, WHERE AN EKG WAS PERFORMED WITH NORMAL RESULTS AND NO ADDITIONAL ABNORMALITIES IDENTIFIED. THE USER REPORTED THAT THE SHCOK DID NOT RESULT IN ANY VISIBLE SKIN DAMAGE AND THERE WAS NO BURN MARKS PRESENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25006453 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP AND CLOSE ORIGINAL REPORT 3031944951-2025-00003.

  Patient problems: Burn(s)

  MAUDE report 22036786 ↗