Ulthera System Control Unit UC-1 Rev. LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840763100254), received between Oct 25, 2017 and Dec 3, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SPONTANEOUS REPORT RECEIVED FROM (B)(6) AFFILIATE ON (B)(6)2024 CONCERNING A 41-YEAR-OLD FEMALE PATIENT. ACCORDING TO THE REPORT, THE PATIENT HAD ULTHERAPY PERFORMED ON THE LOWER FACE USING STANDARD PROTOCOL WITH ULTHERA DS 4-4.5, DS 7-3.0, AND DS 10-1.5 TRANSDUCERS (TOTAL LINES DELIVERED: (B)(4)). TREATMENT WAS PERFORMED IN (B)(6) 2023 WITH A VERY EXPERIENCED THERAPIST WHO HAS BEEN PERFORMING ULTHERAPY FOR MANY YEARS. AFTER THE SESSION, THE PATIENT DEVELOPED A UNILATERAL DENT IN THE RIGHT POSTERIOR JAWLINE AREA. FOLLOW-UP INFORMATION WAS RECEIVED ON 31-OCT-2024. ACCORDING TO THE REPORT, THE PATIENT IS A 41-YEAR-OLD, CAUCASIAN, FEMALE TREATED WITH ULTHERA SYSTEM ON (B)(6)2023 ON THE LOWER FACE USING DS 4-4.5, DS 7-3.0, AND DS 10-1.5 TRANSDUCERS. A TOTAL OF (B)(4) LINES WERE DELIVERED. THE PATIENT WAS GIVEN 800MG IBUPROFEN AND 1000MG PARACETAMOL ORALLY AND TOPICAL LMX4 WAS APPLIED BUT REMOVED PRIOR TO TREATMENT. THE PATIENT'S CONDITION IMMEDIATELY AFTER TREATMENT WAS NOTED AS NOTHING UNUSUAL. CURRENTLY, THE PATIENT'S CONDITION IS ATROPHY IN THE RIGHT POSTERIOR JAWLINE AND NO SYMPTOMS HAVE RESOLVED. THE PATIENT HAS A HISTORY OF NEEDLING, BUT NO HISTORY OF ULTHERA TREATMENTS. THE

  Patient problems: Insufficient Information

  MAUDE report 20836835 ↗
• InjuryOct 25, 2017Improper 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

  ON (B)(4) 2017, A MERZ FIELD CLINICAL SPECIALIST IN (B)(4) BECAME AWARE OF A (B)(6) YEAR OLD, FEMALE PATIENT WHO EXPERIENCED "INFLAMMATION AND ERYTHEMA OR INTENSE REDNESS IN THE CHEEKS AND NECK" POST TREATMENT. "DUE TO THE INFLAMMATORY REACTION, [THE FIELD CLINICAL SPECIALIST] RECOMMENDED APPLYING LOCAL COLD AND 1% TOPICAL HYDROCORTISONE CREAM AND SHE PROVIDED THE PATIENT WITH A MEDICAL SAMPLE TUBE FOR THE PATIENT TO APPLY UNINTERRUPTEDLY FOR 1 WEEK AT NIGHT. ACCORDING TO [THE FIELD CLINICAL SPECIALIST], DURING THE PHYSICAL EXAMINATION DID NOT FIND ANY CLINICAL DATA THAT COULD GENERATE A REACTION OF THIS TYPE; IN THE INTERVIEW THE PATIENT REPORTED THAT SHE HAD RECENTLY RETURNED FROM (B)(6) AND THAT SHE CAME "TANNED" TO THE DEMONSTRATION OF THE DEVICE." ON (B)(6) 2017, IMAGES WERE CAPTURED AND THEN SENT VIA EMAIL ON (B)(6) 2017 INDICATING THAT THE "PATIENT IS SHOWING BURNED MARKS ALL AROUND THE FACE." THE FIELD CLINICAL SPECIALIST "RECOMMENDED: APPLICATION OF LOCAL COLD; USE OF TOPICAL STEROIDS OF TYPE (HYDROCORTISONE / BETAMETHASONE) FOR 8 TO 10 DAYS EVERY 12 HOURS; SOOTHING OR DESENSITIZING CREAMS (CICABIO ARNICA, ROSELIANE CREAM, TOLERIANE ULTRA FLUID FOR SENSITIVE SKIN, ROSELIAC

  Patient problems: Burn(s); Erythema; Inflammation

  MAUDE report 6978708 ↗