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

Summary

The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 07613327278286), received between Apr 18, 2018 and Apr 23, 2026 — classified as 9 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (44 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 240 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 26 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION OR UNINTENDED EXCESSIVE SPEED OF THE ZOOM. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965278 ↗
• MalfunctionApr 23, 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 JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES 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 24965272 ↗
• 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 32 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM; UNINTENDED MOTION OR UNINTENDED EXCESSIVE SPEED. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183349 ↗
• 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 (B)(6) 2025. THIS REPORT SUMMARIZES 3 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 24183347 ↗
• MalfunctionJan 26, 2026Mechanical Jam

  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 STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183139 ↗
• 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 10 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 23393802 ↗
• MalfunctionOct 27, 2025Positioning Failure; Positioning Failure

  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 FALSE LATCH OF SIDERAIL. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393799 ↗
• MalfunctionOct 27, 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 2 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 23393796 ↗
• MalfunctionOct 27, 2025Unintended System Motion; Unintended System Motion

  THIS REPORT NOW SUMMARIZES 30 MALFUNCTION EVENT(S), INSTEAD OF 31.

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

  MAUDE report 23393416 ↗
• MalfunctionOct 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393234 ↗
• MalfunctionApr 28, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF SIDERAIL. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919968 ↗
• MalfunctionApr 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 23 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 21912093 ↗
• MalfunctionApr 25, 2025Intermittent Loss of Power; Intermittent Loss of Power

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911907 ↗
• MalfunctionApr 25, 2025Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED STEER MECHANISM IS DIFFICULT TO ENGAGE/DISENGAGE. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911579 ↗
• MalfunctionApr 25, 2025Grounding Malfunction; Grounding Malfunction

  THIS REPORT SUMMARIZES 10 MALFUNCTION EVENTS, 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 21911547 ↗
• MalfunctionApr 25, 2025Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES 30 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED UNINTENDED DIRECTION OF THE ZOOM OR UNINTENDED EXCESSIVE SPEED OF THE ZOOM. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911536 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911535 ↗
• MalfunctionApr 25, 2025Electrical /Electronic Property Problem; Fluid/Blood Leak; Electrical /Electronic Property Problem; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911453 ↗
• MalfunctionApr 25, 2025Electrical /Electronic Property Problem; Unintended System Motion; Electrical /Electronic Property Problem; Unintended System Motion

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT AND 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 21911293 ↗
• MalfunctionJan 30, 2025Mechanical Jam; Mechanical Jam

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY ENGAGING OR DISENGAGING THE BRAKES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273448 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Fluid/Blood Leak; Electrical /Electronic Property Problem; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED ACCESSIBLE AC CURRENT AND FLUID LEAKING ONTO THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273429 ↗
• MalfunctionJan 27, 2025Intermittent Loss of Power; Intermittent Loss of Power

  THIS REPORT SUMMARIZES 12 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SUDDEN LOSS OF THE ZOOM DRIVE OR THE ZOOM WHEEL UNEXPECTEDLY RETRACTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241387 ↗
• MalfunctionJan 27, 2025Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED FALSE LATCH OF THE SIDERAIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241369 ↗
• MalfunctionJan 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 14 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 21241365 ↗
• MalfunctionJan 27, 2025Grounding Malfunction; Grounding Malfunction

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241363 ↗

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