ProCuity 3009PX-ZMX-600Recalls & reported problems
Stryker Corporation · ProCuity ZMX + Isolibrium PE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker ProCuity ZMX hospital bed is an adjustable, electric bed used in patient care. Reports mostly describe electrical and electronic problems, the bed section dropping unexpectedly, unintended movement, intermittent loss of power, and sharp metal edges. There are 63 reports, no deaths and 1 injury. One open recall, started in August 2023, says some beds were shipped missing electrical safety test values, creating a risk of tissue burns or shock.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 07613327541328), received between Jul 28, 2021 and Jan 27, 2026 — classified as 1 injury, 62 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (13 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.
Reports received per month
Recalls naming this device
- Aug 30, 2023Open, Classified
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Z-0435-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Electrical /Electronic Property Problem13
- Intermittent Loss of Power12
- Unintended System Motion12
- Incorrect Measurement10
- No Audible Alarm5
- Sharp Edges5
- Device Fell4
- Fire2
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Bruise/Contusion2
- Fall2
- Pain2
- Hyperextension1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
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 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 24189132 ↗MalfunctionJan 27, 2026Unintended System Motion
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 UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189128 ↗MalfunctionJan 27, 2026Sharp Edges
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 ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189127 ↗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 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FOWLER UNEXPECTED DROP/COLLAPSE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT THAT EXPERIENCED PAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23384152 ↗MalfunctionJul 23, 2025Intermittent Loss of Power; Intermittent Loss of Power
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579150 ↗MalfunctionJul 23, 2025Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22578974 ↗MalfunctionJul 23, 2025Unintended System Motion; Unintended System Motion
THIS REPORT SUMMARIZES 43 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22578957 ↗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. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED A FALL. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: Fall
MAUDE report 22578944 ↗MalfunctionApr 29, 2025No 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. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925753 ↗MalfunctionApr 28, 2025Intermittent Loss of Power; Intermittent Loss of Power
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ZOOM UNEXPECTEDLY RETRACTS/DISENGAGES DURING USE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919797 ↗MalfunctionApr 28, 2025Unintended System Motion; Unintended System Motion
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, 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 21919777 ↗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 21919428 ↗MalfunctionMar 11, 2025Fire; Fire
IT WAS REPORTED THAT THE OUTLET OF THE FOOT OF THE BED CAUGHT FIRE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21576969 ↗MalfunctionJan 30, 2025Incorrect Measurement; Incorrect Measurement
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INACCURATE SCALE READINGS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 21274434 ↗MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 2 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 21274432 ↗MalfunctionJan 28, 2025No Audible Alarm; No Audible Alarm
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A FAILURE TO ALARM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252210 ↗MalfunctionJan 28, 2025Unintended System Motion; Unintended System Motion
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM DRIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252208 ↗MalfunctionJan 28, 2025Intermittent Loss of Power; Intermittent Loss of Power
THIS REPORT SUMMARIZES 9 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE ZOOM DRIVE SUDDENLY STOPPING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252203 ↗MalfunctionOct 29, 2024Device Fell; Device Fell
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SIDERAIL UNEXPECTED DROP/COLLAPSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20556186 ↗MalfunctionOct 28, 2024Intermittent Loss of Power; Intermittent Loss of Power
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ZOOM SUDDENLY STOPS OR ZOOM UNEXPECTEDLY RETRACTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547882 ↗MalfunctionOct 28, 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 20547119 ↗MalfunctionJul 26, 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 19838477 ↗MalfunctionJul 26, 2024Intermittent Loss of Power; Intermittent Loss of Power
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ZOOM SUDDENLY STOPS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19838475 ↗MalfunctionJul 26, 2024Unintended System Motion; Patient Device Interaction Problem; Unintended System Motion; Patient Device Interaction Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM AND USER ENTRAPPED IN COMPONENT. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED BRUISE/CONTUSION.
Patient problems: Bruise/Contusion
MAUDE report 19838469 ↗MalfunctionApr 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19160026 ↗
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- InTouch 2141Stryker Corporation · BED, AC-POWERED ADJUSTABLE HOSPITAL2 deaths361 reports
- Citadel Plus FX811B3B4AMABBArjohuntleigh AB · BED, AC-POWERED ADJUSTABLE HOSPITAL2 deaths358 reports
- TotalCare® Bed P1900QHill-Rom, Inc. · BED, AC-POWERED ADJUSTABLE HOSPITAL317 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.