ProCuity 3009PX-L-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327541168), received between Apr 22, 2024 and Jan 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2023Open, Classified

   Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.

   Z-0425-2024 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionJan 30, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS, INSTEAD OF 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274468 ↗
• MalfunctionApr 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, 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 19159991 ↗