ProCuity 3009PX-LEX-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 07613327541229), received between Apr 23, 2021 and Apr 23, 2026 — classified as 1 death, 2 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (14 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-0429-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Device Fell

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966912 ↗
• DeathApr 9, 2026No Audible Alarm

  IT WAS REPORTED THAT THE BED EXIT FAILED TO ALARM WHEN THE PATIENT GOT OUT OF THE BED. THE PATIENT WAS FOUND BY STAFF ON THE FLOOR IN A STATE OF CARDIAC ARREST. THE PATIENT REPORTEDLY PASSED AWAY.

  Patient problems: Cardiac Arrest; Fall

  MAUDE report 24832929 ↗
• MalfunctionJan 27, 2026No Audible Alarm

  NO NEW INFORMATION.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187995 ↗
• MalfunctionJan 27, 2026Device Fell

  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 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187994 ↗
• MalfunctionOct 24, 2025Sharp Edges; Sharp Edges

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384146 ↗
• MalfunctionOct 24, 2025Positioning Failure; Positioning Failure

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384137 ↗
• MalfunctionOct 24, 2025Device Fell; Device Fell

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384136 ↗
• MalfunctionJul 25, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INCORRECT MEASUREMENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608938 ↗
• MalfunctionJul 23, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578953 ↗
• MalfunctionJul 23, 2025Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES 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 22578884 ↗
• MalfunctionJul 23, 2025No Audible Alarm; No Audible Alarm

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL CONDITION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578737 ↗
• MalfunctionApr 28, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919847 ↗
• MalfunctionApr 28, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INCORRECT MEASUREMENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919815 ↗
• MalfunctionApr 28, 2025No Audible Alarm; No Audible Alarm

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES, EXPERIENCED CLINICIAN NOT ALERTED/AWARE OF POSSIBLE PATIENT FALL. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT WITH A FALL; NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919647 ↗
• MalfunctionApr 28, 2025Grounding Malfunction; Grounding Malfunction

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED GROUND PATH COMPROMISED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919645 ↗
• MalfunctionApr 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919640 ↗
• MalfunctionJan 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE A PATIENT HAD SUSTAINED A MINOR INJURY AFTER CUTTING THEIR LEG ON A SMALL METAL TAB THAT IS PART OF THE PRODUCT'S DESIGN.

  Patient problems: Laceration(s); Pain

  MAUDE report 21274356 ↗
• MalfunctionJan 30, 2025No Audible Alarm; No Audible Alarm

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274355 ↗
• MalfunctionJan 30, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INACCURATE SCALE READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274354 ↗
• MalfunctionJan 28, 2025Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UN-COMMANDED MOTION OF THE ELECTRONIC POSITIONING FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251427 ↗
• MalfunctionJan 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 5 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 21251425 ↗
• MalfunctionJan 28, 2025Device Fell; Device Fell

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SIDERAIL OR FOWLER COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251423 ↗
• MalfunctionOct 29, 2024Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED LIFT DOES NOT STOP LOWERING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20560262 ↗
• MalfunctionOct 25, 2024Device Fell; Device Fell

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540007 ↗
• MalfunctionOct 25, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 2 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 20536228 ↗