EPIC II 2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07613327348231), received between Apr 24, 2018 and Apr 28, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (15 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, 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 21919408 ↗
• 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 21273443 ↗
• MalfunctionOct 25, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED INCORRECT MEASUREMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535441 ↗
• MalfunctionJul 26, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SCALE MEASURED WEIGHT INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839270 ↗
• MalfunctionJul 27, 2021Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED AN INACCURATE SCALE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235147 ↗
• MalfunctionApr 22, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE ARE EXPOSED BARE WIRES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710882 ↗
• MalfunctionApr 22, 2021Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE IS REDUCED/INADEQUATE BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710878 ↗
• MalfunctionFeb 9, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE HAD REDUCED/INADEQUATE BRAKE FORCE. 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 11303098 ↗
• MalfunctionJan 29, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE SCALE MEASURED WEIGHT INACCURATE. 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 11251936 ↗
• MalfunctionJan 26, 2021Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230997 ↗
• MalfunctionJul 24, 2020Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10321334 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WAS REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10309046 ↗
• MalfunctionApr 28, 2020Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10004900 ↗
• MalfunctionApr 27, 2020Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE HAD PHANTOM MOTION.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10001488 ↗
• MalfunctionApr 27, 2020Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10001180 ↗
• MalfunctionJan 28, 2020Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9638817 ↗
• MalfunctionJan 27, 2020Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9633995 ↗
• MalfunctionOct 25, 2019Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES <NOE> 7 </NOE> MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9238816 ↗
• MalfunctionOct 25, 2019Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THERE WERE EXPOSED BARE WIRES AND THE UNIT HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9238807 ↗
• MalfunctionOct 25, 2019Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9238806 ↗
• MalfunctionJul 29, 2019Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8835840 ↗
• MalfunctionApr 26, 2019Mechanical Problem; Mechanical Problem

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE UNIT HAD REDUCED BRAKE FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8554973 ↗
• MalfunctionApr 26, 2019Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8554964 ↗
• MalfunctionJan 28, 2019Unintended System Motion; Unintended System Motion

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED .THE BED HAD PHANTOM MOTION THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8280995 ↗
• MalfunctionJan 28, 2019Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE SCALE WAS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8280786 ↗