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

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840763100179), received between Oct 13, 2016 and Dec 21, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Sparking” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022No Display/Image; Sparking; No Display/Image; Sparking

  ON (B)(6) 2022, A CUSTOMER REPORTED VIA PHONE CALL AN ULTHERA CONTROL UNIT THAT WAS GIVING A BLANK SCREEN. UPON TURNING OFF THIS DEVICE AND POWERING BACK ON, SPARKS WERE OBSERVED EMITTING FROM THE CONNECTION WHERE THE POWER CORD CONNECTS TO THE BACK OF THE CONTROL UNIT. TROUBLESHOOTING WAS PERFORMED BY REQUESTING THE USER TO UNPLUG THE DEVICE AND ENSURE THE POWER CORD WAS FULLY SEATED INTO THE CONTROL UNIT. UPON CONFIRMATION OF THE POWER CORD BEING FULLY SEATED, THE DEVICE WAS AGAIN PLUGGED INTO AN OUTLET. WHEN THE UNIT WAS PLUGGED IN, SPARKS WERE REPORTEDLY EMITTING FROM THE SAME LOCATION ON THE BACK OF THE CONTROL UNIT. THE PRACTICE CONFIRMED NO INJURY TO USER OR ANY PATIENTS WERE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025842 ↗
• MalfunctionDec 21, 2022Failure to Power Up; Sparking; Failure to Power Up; Sparking

  WHILE TROUBLESHOOTING ISSUES WITH AN ULTHERA SYSTEM FOR AN UNRELATED EVENT ON (B)(6) 2022, A CUSTOMER ALLEGED THAT SPARKS EMITTED FROM THE BACK OF THEIR CONTROL UNIT. THE USER STATED THE SPARKS ORIGINATED FROM THE AREA OF THE CONNECTION OF THE POWER CORD TO THE BACK OF THE MACHINE, AND OCCURRED WHEN THE SYSTEM WAS TURNED ON. FOLLOWING THIS EVENT, THE SYSTEM WOULD NO LONGER TURN ON. THE USER STATED THE PLUG APPEARED INTACT WITH NO SIGN OF FRAYING, AND THE POWER CORD WAS FULLY SEATED INTO THE CONTROL UNIT. THE USER WAS DIRECTED TO CEASE USE OF THIS SYSTEM IMMEDIATELY. THE PRACTICE CONFIRMED NO INJURY TO USER OR ANY PATIENTS WERE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025772 ↗
• MalfunctionJul 6, 2021Sparking; Sparking

  DURING A PHONE CALL WITH A PRACTICE FOR AN UNRELATED EVENT ON (B)(6) 2021, MERZ ULTHERA RECEIVED INFORMATION AN ULTHERA CONTROL UNIT WAS EMITTING SPARKS FROM THE BACK OF THE UNIT WHERE THE POWER CORD PLUGS INTO THE BACK OF THE UNIT. THIS ISSUE OCCURRED WHEN THE USER MOVED THIS DEVICE TO ANOTHER LOCATION WITHIN THE PRACTICE AND PLUGGED IT INTO THE WALL OUTLET. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125993 ↗
• MalfunctionMay 6, 2021Sparking; Sparking

  DURING A PHONE CALL WITH A PRACTICE FOR AN UNRELATED EVENT ON (B)(6) 2021, MERZ ULTHERA RECEIVED INFORMATION AN ULTHERA CONTROL UNIT WAS EMITTING SPARKS FROM THE BACK OF THE UNIT WHERE THE POWER CORD PLUGS INTO THE BACK OF THE UNIT. THIS ISSUE OCCURRED WHEN THE USER MOVED THIS DEVICE TO ANOTHER LOCATION WITHIN THE PRACTICE AND PLUGGED IT INTO THE WALL OUTLET. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787534 ↗
• InjuryOct 3, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A MERZ AFFILIATE LOCATED IN (B)(6) NOTIFIED ULTHERA INC., MERZ DEVICE INNOVATION CENTER ON (B)(6) 2015 ABOUT A PATIENT WHO ALLEGEDLY EXPERIENCED THIRD-DEGREE BURNS FOLLOWING AN ULTHERAPY TREATMENT WITH TRANSDUCER SERIAL NUMBER (B)(4), HANDPIECE SERIAL NUMBER (B)(4), AND CONTROL UNIT SERIAL NUMBER (B)(4). THE TREATMENT WAS REPORTEDLY PERFORMED UNDER ANESTHESIA AND RESULTED IN SCARRING ON THE LEFT CHEEK WITH SWELLING IN THE NECK FOR APPROXIMATELY 10 DAYS.

  Patient problems: Edema; Full thickness (Third Degree) Burn

  MAUDE report 6909760 ↗
• InjuryDec 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRACTICE REPORTED TO MDIC ON (B)(6) 2016 A PATIENT WHO IS EXPERIENCING VISUAL AND PALPABLE BILATERAL "RIDGES" ON HER CHEEKS 10 MONTHS POST FULL FACE ULTHERAPY TREATMENT. TO DATE, PATIENT IS NOT RESOLVING. THE PRACTICE IS NOT RESPONDING TO MDIC REQUESTS TO OBTAIN MORE INFORMATION ON THE CASE. PER ULTHERA IFU, THE POSSIBILITY OF SCAR FORMATION MAY EXIST IF INCORRECT TREATMENT TECHNIQUE IS USED. PRACTICE DEVIATED FROM ULTHERA'S SUGGESTED TREATMENT GUIDELINES AND USED 3X THE RECOMMENDED TREATMENT LINES, OVER TREATMENT OF THE PATIENT IS THE SUSPECTED CAUSE OF THE INJURY. REVIEW OF THE SUPPORT LOG SHOWS NO DEVICE MALFUNCTION.

  Patient problems: Scar Tissue

  MAUDE report 6201433 ↗
• InjuryOct 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRACTICE REPORTED TO ULTHERA ON 3/10/2016 A PATIENT WHO IS VERY SLIM, EXPERIENCED A SUDDEN ONSET OF A SHARP, SEVERE PAIN BEGINNING IN THE RIGHT, ANTERIOR NECK, RADIATING DOWN THE RIGHT SHOULDER AND ALL THE WAY DOWN THE ARM TO HER MIDDLE FINGER AFTER ULTHERAPY FACE AND NECK TREATMENT ON (B)(6) 2016. THE PATIENT HAS HAD CONTINUED DISCOMFORT WITH MOVEMENT OF HER RIGHT UPPER EXTREMITY AND IS MOST SEVERE FROM THE ELBOW DOWN INTO THE FOREARM. PERIODIC FOLLOW UPS WITH THE PRACTICE INDICATE GRADUAL RESOLUTION BUT PATIENT HAS NOT FULLY RESOLVED. CAUSE OF PAIN IS UNKNOWN, THE CASE IS LOST FOR FOLLOW UP. A SYSTEM SUPPORT LOG WAS REVIEWED AND SHOWED NO DEVICE MALFUNCTION.

  Patient problems: Pain

  MAUDE report 6026012 ↗