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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840763100230), received between Feb 21, 2017 and Oct 13, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TREATMENT PROVIDER REPORTED TO MERZ/ULTHERA ON (B)(6) 2022 VIA PHONE CALL REGARDING A PATIENT THAT WAS TREATED WITH ULTHERAPY. ACCORDING TO THE REPORT, THE PATIENT CAME INTO THE PRACTICE "APPROXIMATELY 1 WEEK AGO" AND REPORTED RECEIVING WELTS ON HER NECK AND CHEEK FROM AN ULTHERAPY TREATMENT RECEIVED ON (B)(6) 2022. THE PROVIDER INDICATED THAT THEY DID NOT IDENTIFY ANYTHING ON THE PATIENT'S CHEEK; HOWEVER, THEY DID IDENTIFY HYPO-PIGMENTATED MARKINGS ON THE NECK. DURING FOLLOW UP FOR THIS INITIAL REPORT, THE TREATMENT PROVIDER INDICATED VIA PHONE CALL THAT THEY "BELIEVE THE SCAR WOULD NOT BE PERMANENT, BUT WOULD TAKE A LONG TIME TO HEAL." THE PRACTICE INDICATED THIS PATIENT HAD ULTHERAPY TREATMENTS THREE TIMES PRIOR TO THIS TREATMENT ON (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021. FOR THE (B)(6) 2022 TREATMENT, THE REPORTER STATED THE PATIENT WAS TREATED ON THE FACE AND NECK WITH 310 LINES USING A DS 10-1.5 (1.5 MM DEPTH). A REVIEW OF THE SUPPORT LOG FOUND THAT THIS PATIENT WAS ACTUALLY TREATED WITH 360 LINES, AND REVEALED RECOMMENDED GUIDELINES WERE FOLLOWED DURING TREATMENT. THE TREATMENT PROVIDER STATED THAT NO MALFUNCTIONS OCCURRED DURING TREATMENT, AND ALL EQUIPMENT PERFORMED A

  Patient problems: Skin Discoloration; Wheal(s)

  MAUDE report 15601474 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-JUN-2020, ULTHERA RECEIVED INFORMATION REGARDING A REPORT OF UNKNOWN PATIENT INJURY RESULTING FROM ULTHERAPY FROM MERZ (B)(6) AFFILIATE VIA EMAIL. ON 16-OCT-2020, ULTHERA RECEIVED ADDITIONAL INFORMATION FROM A MERZ (B)(6) AFFILIATE REGARDING AN ADVERSE EVENT ASSOCIATED WITH AN ULTHERAPY TREATMENT. PER THE INFORMATION RECEIVED, THE AFFILIATE REPORTED "DOCTOR COMMENTED THAT THERE WAS MILD REDNESS OVER THE NECK OF THE PATIENT POST-TREATMENT, AND THUS PRESCRIBED HYDROCORTISONE 1% LA BD FOR FIVE DAYS. PATIENT COMPLAINED OF BLISTER AT JUNCTION OF SUBMENTAL AND NECK AT NIGHT ON (B)(6) 2020, AND THE BLISTER PERFORATED ON (B)(6) 2020. THE PATIENT HAS THEN VISITED A DERMATOLOGIST ON (B)(6) 2020 FOR WOUND MANAGEMENT. PER PATIENT REPORT, THE DERMATOLOGIST COMMENTED THAT AFTER THE SCAB FALL OFF, RED MARK MAY LEFT AT THE BEGINNING, AND TURN INTO BROWN MARK. IT MAY TAKE FEW MONTHS FOR RECOVER. ON THE NEXT FOLLOW-UP SESSION ON (B)(6) 2020, THE DERMATOLOGIST DIAGNOSED THAT THE PATIENT HAS POST-ULTHERAPY BULLA." ON 24-OCT-2020, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PRACTICE CONTAINING PATIENT AND TREATMENT DETAILS AS WELL AS STATING THE ULTHERA EQUIPMENT PERFORMED AS INTENDED AND NO MAL

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 12923904 ↗
• InjuryJul 25, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2017 A (B)(6) FIELD REPRESENTATIVE RECEIVED AN EMAIL MAKING THEM AWARE OF A FEMALE PATIENT WHO RECEIVED AN ULTHERAPY TREATMENT ON (B)(6) 2016 WITH DEVICE SERIAL NUMBER (B)(4). PATIENT ALLEGES THAT AS A RESULT OF THE TREATMENT, SHE DEVELOPED LEFT-SIDED SEVERE EDEMA, ERYTHEMA, AND DISCOMFORT STARTING IN THE CHEST WALL AND MOVING UP THE LEFT SIDE OF HER NECK. PATIENT SOUGHT MEDICAL TREATMENT ON (B)(6) 2016 FOR NECK STIFFNESS, REDNESS AND WARMTH. SUBSEQUENT BLOOD TESTS REVEALED ELEVATED WHITE BLOOD CELL COUNT. A CT SCAN (DATE UNKNOWN) DEMONSTRATED EXTENSIVE MYOSITIS AND INTRAMUSCULAR EDEMA. PATIENT ALLEGES THAT SHE EXPERIENCED A DISRUPTION OF THE INTEGRITY OF HER SKIN LEADING TO A BACTERIAL INFILTRATION ALONG THE MUSCLE AND SKIN LEVELS CAUSING A MYOSITIS AND CELLULITIS AND A THIRD-DEGREE BURN.

  Patient problems: Burning Sensation; Cellulitis; Edema; Patient Problem/Medical Problem

  MAUDE report 6742770 ↗
• InjuryFeb 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTH CARE PROVIDER REACHED OUT TO ULTHERA ON SEPTEMBER 15, 2016 STATING THEY HAD AN ADVERSE EVENT, BUT DID NOT SPECIFIC THE EVENT DETAILS. ON 11/21/2016 THE HEALTH CARE PROVIDER REPORTED THE PATIENT IS HAVING HEADACHES AFTER HAVING THE FOREHEAD REGION TREATED (B)(6) 2016 WITH OBJECTIVE TO ELEVATE BROWS. THE PATIENT SUBSEQUENTLY DEVELOPED "THUNDERCLAP HEADACHES" ASSOCIATED WITH NAUSEA AND SWEATING. THE PATIENT IS BEING TREATED BY A NEUROLOGY SPECIALIST WHO STATED THE ULTRASOUND MAY BE RESPONSIBLE FOR STIMULATION OF THE TRIGEMINAL NERVES AND THE TRIGEMINAL GANGLION, CAUSING THE REPORTED SYMPTOMS.

  Patient problems: Headache; Vasoconstriction

  MAUDE report 6345490 ↗