ProCuity 3009PX-Z-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327541243), received between Jan 24, 2024 and Apr 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED REDUCED/INADEQUATE BRAKE FORCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT WITH A FALL; NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: Fall

  MAUDE report 21920108 ↗
• MalfunctionJan 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252204 ↗
• MalfunctionJan 24, 2024No Audible Alarm; No Audible Alarm

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL CONDITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571838 ↗