CloudTMSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04650075330296), received between Aug 21, 2025 and Aug 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Off-Label Use; Off-Label Use

  ON (B)(6) 2025, THE CUSTOMER CONTACTED THE AUTHORIZED AGENT'S OFFICE TO TELL THAT SHE EXPERIENCED A SEIZURE WHILE TREATING HERSELF WITH THE MACHINE, USING AN UNKNOWN PROTOCOL THAT, ACCORDING TO HER, WAS DESIGNED BY ONE OF HER FRIENDS. THE CUSTOMER SENT A VIDEO OF THAT INCIDENT, THE VIDEO BEING DATED (B)(6) 2025, SHOWING SHE WAS ADMINISTERING THAT TREATMENT TO HERSELF, WITH NO ONE SEEN IN THE ROOM WITH HER. SHE IS SEEN STANDING UP WITH THE COIL ON HER HEAD AND THEN FALLING DOWN AND GOING OUT OF CAMERA VIEW, SO THERE WAS NO CONFIRMATION BY VIDEO RECORDING, OR BY ANY OBSERVER OF WHAT HAPPENED DURING OR AFTER THE FALL. ON (B)(6) 2025, THE CUSTOMER EMAILED THE AUTHORIZED AGENT TELLING THAT SHE HAD BEEN TAKEN TO THE EMERGENCY ROOM AFTER THE FALL, AND WAS DISCHARGED WITH "SEIZURE AND CONCUSSION PRECAUTIONS", BUT THERE WAS NO MENTION IN HER EMAIL OF ANY EXAM FOR SEIZURES OR EEG RECORDING DURING HER EMERGENCY ROOM VISIT. THE CUSTOMER RETURNED THE MACHINE AND ITS LAPTOP, WHERE IT WAS WITNESSED THAT SHE HAD INSTALLED A TMS PROTOCOL THAT WAS NOT INCLUDED IN HER LAPTOP PRIOR TO SHIPMENT. ONCE THE MACHINE WAS BACK, IT WAS COMPLETELY CHECKED, ITS FUNCTIONING WAS TESTED AND IT WAS FOUND THAT THE D

  Patient problems: Convulsion/Seizure

  MAUDE report 22861152 ↗