Midas Rex® EF201 (UDI 00643169304475)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169304475), received between Jun 8, 2017 and Jun 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (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.

• MalfunctionJun 8, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT INTRAOPERATIVE, THE FOOT CONTROL WAS AT REST/INACTIVE AND ACTIVATED THE HANDPIECE ON ITS OWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6622345 ↗