ProCuity 3009PX-LE-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327541182), received between Oct 24, 2022 and Jan 27, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 reports).

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. How this data works · Data updated Oct 13, 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-0427-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026No Audible Alarm

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL . NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187992 ↗
• MalfunctionOct 24, 2025No Audible Alarm; No Audible Alarm

  NO NEW INFORMATION

  Patient problems: Fall

  MAUDE report 23384018 ↗
• MalfunctionJul 23, 2025Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UN-COMMANDED MOTION OF THE ELECTRONIC POSITIONING FUNCTIONS. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578446 ↗
• MalfunctionJan 30, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED A FAILURE OF THE LIFT TO STOP LOWERING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274470 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274466 ↗
• MalfunctionJul 26, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838183 ↗
• MalfunctionApr 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159386 ↗
• MalfunctionOct 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SIDERAIL TRIP. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007335 ↗
• InjurySep 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAN AN EMPLOYEE TRIPPED OVER THE SIDERAIL WHEN IT WAS LOWERED AND HAD TO TAKE WORKER'S COMPENSATION WHILE AWAITING SURGERY AS A RESULT OF A TORN ROTATOR CUFF. THE BED WAS NOT ALLEGED TO HAVE HAD ANY COMPONENT LEVEL DEFECT.

  Patient problems: Insufficient Information; Muscle/Tendon Damage

  MAUDE report 17792946 ↗
• InjurySep 6, 2023No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE DEVICE DID NOT ALARM WHEN PATIENT EXITED THE BED. AS A RESULT, THE PATIENT FELL AND SUSTAINED A HIP/PELVIC FRACTURE.

  Patient problems: Hip Fracture; Insufficient Information

  MAUDE report 17693117 ↗
• MalfunctionJul 19, 2023Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNEXPECTED FOWLER DROP. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350158 ↗
• MalfunctionOct 24, 2022Electrical /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 15657478 ↗