Actiwatch Actiwatch Spectrum PlusRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959021440), received between Oct 10, 2023 and Oct 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Melted” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2023Melted; Melted

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE PORT WAS DAMAGED WHILE BEING CHARGED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION, THE MANUFACTURER OBSERVED THAT DEVICE WAS DAMAGED WITH THE CASE MELTED AT THE USB PORT. THEY ARE UNABLE TO CONFIRM HOW DAMAGE OCCURRED AND UNABLE TO REPAIR THE DEVICE. THE DEVICE WAS SCRAPPED AND REPLACED UNDER WARRANTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18027830 ↗
• MalfunctionOct 10, 2023Melted; Melted

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE PORT WAS DAMAGED WHILE BEING CHARGED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE EVALUATION REVEALED THE DEVICE WAS DAMAGED WITH THE CASE MELTED AT THE USB PORT. THEY ARE UNABLE TO CONFIRM HOW DAMAGE OCCURRED AND UNABLE TO REPAIR THE DEVICE. THE DEVICE WAS SCRAPPED AND REPLACED UNDER WARRANTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902700 ↗