XPS® 1895400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490048880), received between May 30, 2017 and Jul 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED BY THE HEALTHCARE PROVIDER (HCP) THAT THE HANDPIECE IS WORKING EVEN WITHOUT PRESSING FOOT SWITCH. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195869 ↗
• MalfunctionMay 30, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT POST-OPERATIVE THE FOOTSWITCH WAS AT REST/INACTIVE AND THEN TURNED ON BY ITSELF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6599713 ↗