Deep Transcranial Magnetic Stimulation (DTMS) System 104Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290110538026), received between Apr 4, 2025 and Jun 21, 2026 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2026Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY THREE MINUTES INTO THE 23RD TREATMENT USING THE BRAINSWAY H1 TREATMENT (THETA-BURST 600 PULSE PROTOCOL), THE PATIENT BEGAN TO HAVE CONTRACTIONS OF HER RIGHT HAND WHICH STEADILY PROGRESSED UP TO THE ARM IN A JACKSONIAN MANNER. THE PATIENT ALERTED THE TECHNICIAN THAT THEIR HAND WAS CRAMPING. THE TECHNICIAN STOPPED THE MACHINE, MOVED THE PATIENT TO THE FLOOR, NOTIFIED EMS AND THE NURSE PRACTITIONER. THE PATIENT BEGAN TO HAVE A GENERALIZED TONIC-CLONIC SEIZURE WHICH LASTED 1.5 MINUTES FOLLOWED BY A 5-7 MINUTE POSTICTAL PERIOD. THE PATIENT WAS TRANSPORTED TO A LOCAL EMERGENCY ROOM. A CT SCAN SHOWED NO REMARKABLE FINDINGS. THIS APPEARS TO HAVE BEEN A SEIZURE WITH NO KNOWN PRECIPITATING FACTORS.

  Patient problems: Convulsion, Clonic

  MAUDE report 25571926 ↗
• InjuryApr 19, 2026Off-Label Use

  39 YEAR OLD PATIENT WITH MDD HAS A SEIZURE DURING TMS TREATMENT SESSION #23. PATIENT WAS UNRESPONSIVE FOR APPROXIMATELY 12 SECONDS, LOST BLADDER CONTROL AND VOMITED. PATIENT WAS POST ICTAL FOR APPROXIMATELY 25 MINUTES. PATIENT WAS EVALUATED IN THE ER AND RELEASED FOLLOWING NO ABNORMAL FINDINGS ON CT. THE ONLY REMARKABLE FINDINGS FROM ER WAS A UTI. THE PATIENT HAS A FATHER AND BROTHER WITH A HISTORY SEIZURES. FURTHERMORE, THE PATIENT'S MOTOR THRESHOLD WAS RELATIVELY HIGH. CONSEQUENTLY, AFTER INTERNAL MEDICAL REVIEW, THE SEIZURE IS LIKELY ASSOCIATED WITH A GENETIC PREDISPOSITION FOR SEIZURES AND A HIGH MOTOR THRESHOLD.

  Patient problems: Convulsion/Seizure

  MAUDE report 24921078 ↗
• InjuryJul 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT EXPERIENCED A TONIC-CLONIC SEIZURE DURING SECOND STAGE OF DUAL COIL TREATMENT (H7 - ITBS AND THEN H1 DEPRESSION PROTOCOL, OCCURED DURING TRAIN 34/55 OF DEPRESSION PROTOCOL REATMENT). SEIZURE LASTED APPROXIMATELY 3 MINUTES. POST-ICTAL CONFUSION PRESENT. PATIENT REFUSED TO BE TRANSFERRED TO ER. NO SLEEP DEPRIVATION. THE CAUSES OF THE SEIZURE WERE MULTIFACTORIAL. TRANSGENDER INDIVIDUAL WITH MDD AT INCREASED RISK FOR SUBSTANCE USE, WHICH MAY AFFECT TREATMENT SAFETY AND MEDICATION COMPLIANCE. LEFT HAND MOVEMENT DURING H-7 TREATMENT DURING THE FULL COURSE OF TREATMENT, INDICATING CORTICAL SPREAD OR PRIMING TO THE RIGHT CORTEX AND LOWERING OF MOTOR THRESHOLD, WAS NOT RECOGNIZED AS CORTICAL HYPEREXCITABILITY INDICATOR REQUIRING TREATMENT MODIFICATION. PATIENT WAS TREATED WITH DUAL TREATMENT STIMULATION PROTOCOL, WHICH IS OUTSIDE OF THE APPROVED INSTRUCTIONS FOR USE (I.E., OFF LABEL USE). THIS WAS A DEVICE-INDUCED FOCAL MOTOR SEIZURE (JACKSONIAN SEIZURE) THAT WAS HIGHLY PREVENTABLE THROUGH PROPER RISK ASSESSMENT, PROTOCOL ADHERENCE, AND RECOGNITION OF WARNING SIGNS. MULTIPLE FAILURES CONVERGED TO CREATE AN UNSAFE TREATMENT ENVIRONMENT THAT DIRECTLY CONTRIBUTED TO THIS SERIOUS ADVERS

  Patient problems: Convulsion/Seizure

  MAUDE report 22466358 ↗
• InjuryJun 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT EXPERIENCED A GENERALIZED TONIC-CLONIC SEIZURE DURING TREATMENT SESSIONS #18. PATIENT'S RIGHT ARM STIFFEN, FOLLOWED BY THE PATIENT SLUMPING TO THE RIGHT SIDE AND EXHIBITING FULL-BODY SHAKING CONSISTENT WITH GENERALIZED CONVULSIVE ACTIVITY. PATIENT REMAINED UNRESPONSIVE FOR APPROXIMATELY ONE MINUTE FOLLOWING CESSATION OF CONVULSIVE MOVEMENTS. POST-ICTAL CONFUSION PERSISTED FOR APPROXIMATELY FIVE TO SIX MINUTES. NO SIGNIFICANT INJURIES WERE SUSTAINED DURING THE EVENT, THOUGH A POSSIBLE MINOR TONGUE BITE WAS NOTED WITHOUT ASSOCIATED BLEEDING. IMPORTANTLY, NO URINARY OR BOWEL INCONTINENCE OCCURRED DURING OR AFTER THE SEIZURE. PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND WAS SUBSEQUENTLY DISCHARGED HOME THE SAME DAY.

  Patient problems: Convulsion/Seizure

  MAUDE report 22175220 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED A TONIC-CLONIC SEIZURE DURING TREATMENT SESSION #3, WITH LABORED BREATING AND ORAL SECRETIONS. SEIZURE WAS RESOLVED WITHIN 2 MINUTES. INITIALLY, PATIENT WAS LETHARGIC CONFUSED AND NOT ORIENTED, ALTHOUGH THE PATIENT'S SENSORIUM CLEARED AND PATIENT BECAME MORE ALERT AND CONVERSANT WITHIN A FEW MINUTES. PATIENT WAS SENT TO THE ER. CT AND BLOOD WORK WERE NORMAL. NO SEIZURE HISTORY OR FAMILY SEIZURE HISTORY AND NO SLEEP DEPRIVATION. THIS WAS PROBABLY A TMS-PROVOKED SEIZURE.

  Patient problems: Convulsion/Seizure

  MAUDE report 21771664 ↗