Ti-Max X X-SG93Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264517912), received between Jul 24, 2025 and Jul 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of Device” (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.

• InjuryJul 24, 2025Overheating of Device; Overheating of Device

  ON JUNE 30, 2025, NAKANISHI RECEIVED A PHONE CALL FROM A DEALER ABOUT AN NSK HANDPIECE OVERHEATING. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS. - THE EVENT OCCURRED ON (B)(6) 2025. - THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE X-SG93 HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HEAD OF THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A BURN INJURY.

  Patient problems: Burn(s)

  MAUDE report 22584502 ↗