Ulthera System Handpiece UH-2 Rev NRecalls & reported problems
Ulthera, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840763100919), received between Jun 2, 2023 and Jun 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (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 18, 2026.
Most reported problems
Device problems
- Key or Button Unresponsive/not Working1
- Noise, Audible1
- Unintended Electrical Shock1
Patient problems
- Electric Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2023Noise, Audible; Unintended Electrical Shock; Key or Button Unresponsive/not Working; Noise, Audible; Unintended Electrical Shock; Key or Button Unresponsive/not Working
ON 21-JAN-2023, A BELGIUM MERZ/ULTHERA AFFILIATE REPORTED VIA EMAIL A HANDPIECE WITH BUTTON FUNCTION ISSUES. ON 23-JAN-2023, THE AFFILIATE PROVIDED AN UPDATED REPORT FROM THE CUSTOMER STATING THE HANDPIECE WAS ASSOCIATED WITH CODE M AND WAS MAKING STRANGE NOISES. DURING TROUBLESHOOTING, A FULL POWER CYCLE WAS PERFORMED TWO TIMES. DURING THE POWER CYCLE, THE REPORTER STATED "THE NURSE FELT THE SORT OF ELECTRICAL SHOCK IN THE HANDPIECE. SHE WAS NOT TREATING ANYONE AS SHE WAS TESTING HER TRANSDUCERS. SHE DESCRIBED IT AS A LIGHT SHOCK." THE USER REPORTED NO LINGERING SYMPTOMS OR ISSUES OCCURRED. THE REPORTER STATED THERE IS A POSSIBILITY THE SHOCK THE NURSE ENCOUNTERED WAS A STATIC SHOCK; HOWEVER, THIS CANNOT BE CONFIRMED WITH CERTAINTY. NO PATIENT IMPACT WAS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WAS INITIALLY SUBMITTED UNDER AN INCORRECT MANUFACTURER FEI NUMBER: 3006560326-2023-00013. THIS REPORT IS BEINGRESUBMITTED UNDER THE CORRECT NUMBER: 3006560326-2023-00002.
Patient problems: Electric Shock
MAUDE report 17050546 ↗
Other System, Imaging, Pulsed Echo, Ultrasonic devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- Site~Rite 8 Ultrasound System 9770600Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic629 reports
- Site-Rite 9770501Bard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic546 reports
- Transducer X8-2t 989605455171Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic8 recalls19 reports
- Transducer C10-3v 989605409562Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic7 recalls0 reports
- Site~Rite 8 Ultrasound System 9770600YBard Access Systems, Inc. · System, imaging, pulsed echo, ultrasonic330 reports
- Transducer C9-2 989605391092Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
- Transducer S5-1 989605412082Philips Ultrasound LLC · System, imaging, pulsed echo, ultrasonic5 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page