iTero Element 5D Plus cart configuration 211484Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816063020691), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Overheating of Device; Sparking; Overheating of Device; Sparking

  WHEN REMOVING THE PLUG FROM THE SOCKET, FLAMES FORMED AT THE TRANSITION BETWEEN THE PLUG AND THE CABLE AND SPARKS/SMOKE WERE EMITTED FROM THE SOCKET. THE OFFICE REPORTED THAT A PERSON IN THE OFFICE WAS INJURED (NO PATIENT WAS REPORTED TO BE INJURED). UPON ASSESSMENT OF THE EVENT, THE BURN APPEARS TO BE RELATED TO HEAT AND NOT DUE TO ELECTRICAL SHOCK. THE SCANNER OPERATOR HANDS WERE DRY. THERE WAS A MINOR INJURY (SUPERFICIAL BURN) IN THE FINGER THAT DID NOT REQUIRE ANY MEDICAL INTERVENTION.

  Patient problems: Burn(s)

  MAUDE report 17491663 ↗