Spirit Plus 5600Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327284553), received between Jul 29, 2019 and Apr 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, 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 21921703 ↗
• MalfunctionOct 20, 2022Electrical /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 15640582 ↗
• MalfunctionApr 23, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THERE IS ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11715673 ↗
• MalfunctionJan 27, 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 11237326 ↗
• MalfunctionOct 27, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THERE WAS ACCESSIBLE AC CURRENT.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10743658 ↗
• MalfunctionJul 29, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THERE WERE EXPOSED BARE WIRES ON THE POWER CORD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8835625 ↗