Prime Series 1125 (REF 1125-000-000X)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 07613327278323), received between Apr 23, 2018 and Apr 23, 2026 — classified as 2 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (19 reports).

1 other recall cover devices cleared under the same FDA submission (K140095); they may or may not involve this specific model.

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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 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 (B)(6) - (B)(6) 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES 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 24965276 ↗
• MalfunctionJan 26, 2026Device Fell

  THIS REPORT NOW SUMMARIZES 0 MALFUNCTION EVENT(S), INSTEAD OF 1.

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

  MAUDE report 24183378 ↗
• MalfunctionJan 26, 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 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN.

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

  MAUDE report 24183345 ↗
• MalfunctionJan 26, 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 24183344 ↗
• MalfunctionOct 27, 2025Grounding Malfunction; Grounding Malfunction

  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 GROUND PATH COMPROMISED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393420 ↗
• MalfunctionOct 27, 2025Unintended System Motion; Unintended System Motion

  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 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 23393240 ↗
• MalfunctionJul 23, 2025Device Slipped; Device Slipped

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS SLIDES OFF LITTER. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576184 ↗
• MalfunctionJul 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), 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 22576173 ↗
• MalfunctionApr 25, 2025Mechanical Jam; Mechanical Jam

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911748 ↗
• MalfunctionJan 27, 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 21241303 ↗
• MalfunctionJan 27, 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 21241302 ↗
• MalfunctionJan 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FLUID LEAKING ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241300 ↗
• MalfunctionJan 27, 2025Grounding Malfunction; Grounding Malfunction

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED A COMPROMISED GROUND PATH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241299 ↗
• MalfunctionJul 29, 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 1 EVENT WITH PATIENT INVOLVEMENT; NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850103 ↗
• MalfunctionApr 23, 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 19162987 ↗
• MalfunctionApr 22, 2024Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155104 ↗
• MalfunctionJan 24, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, 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 18574331 ↗
• MalfunctionJan 23, 2024Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED BRAKES DIFFICULT TO ENGAGE/DISENGAGE, BRAKES CANNOT BE ENGAGED OR STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563494 ↗
• MalfunctionJan 23, 2024Grounding Malfunction; Grounding Malfunction

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED GROUND PATH COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563493 ↗
• MalfunctionJan 23, 2024Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563446 ↗
• MalfunctionOct 24, 2023Electrical /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 17998680 ↗
• MalfunctionOct 24, 2023Device 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 17998201 ↗
• MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED FLUID LEAKS ONTO FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990472 ↗
• MalfunctionJul 24, 2023Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED SPEED OF THE ZOOM DRIVE OR UNINTENDED DIRECTION OF THE ZOOM DRIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377728 ↗
• MalfunctionJul 20, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 3 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 17365723 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140095. One submission often covers many models, so check the product and lot details in each record.

• Z-1184-2016 · Feb 5, 2016 · Terminated
  Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher