ActiGraph GT9XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853048008015), received between Jul 2, 2019 and Jul 2, 2019.

The most frequently reported specific device problem is “Corroded” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• Jul 2, 2019Corroded

  ACTIGRAPH RECEIVED INFO FROM A CUSTOMER THAT A PARTICIPANT EXPERIENCED A SKIN REACTION ON "BURN" UNDER THE METAL ELECTRICAL CONTACTS OF A DEVICE. THIS DEVICE WAS NOT WORN IN THE NORMAL FASHION, THE WRIST HOLSTER, BUT INSTEAD PHYSICALLY SECURED TO THE USER'S CHEST VIA A TEGADERM PATCH FOR 48 HOURS. THE DISPLAY OF THE DEVICE WAS FACING OUT AND THE DEVICE CONTACT PINS WERE DIRECTLY TOUCHING THE SKIN. THE CUSTOMER REPORTED, THE ELECTRODES [ON THE BACK OF THE DEVICE] WERE CLEARLY CORRODED AND THERE WAS A GREENISH PATINA ON / IN THE PARTICIPANT'S SKIN. THE PARTICIPANT ALSO REPORTED THE "DEVICE FELT WARM (EVEN INDOORS IN AC)." HOWEVER, THE REPORTER CLARIFIED THAT IT WAS NOT A HEAT RELATED INJURY, BUT SPECULATED IT APPEARED TO BE MORE OF A CHEMICAL AND / OR ELECTRICAL REACTION WITH METAL CONTACTS; SPECIFICALLY THE LEFTMOST ELECTRODE. THE PARTICIPANT REPORTED THEY SOUGHT MEDICAL TREATMENT AND THE PHYSICIAN DESCRIBED THE REACTION AS A "2ND DEGREE BURN" AND PRESCRIBED AN ANTIBIOTIC TOPICAL OINTMENT. IT WAS REPORTED TO ACTIGRAPH THAT A SECOND PARTICIPANT WITHIN THE SAME STUDY NOTIFIED THEM OF HAVING SIMILAR SORES BUT WAS MUCH LESS SEVERE AND THEY DID NOT SEEK MEDICAL ATTENTION; IT SHOULD BE NO

  Patient problems: Partial thickness (Second Degree) Burn; Reaction

  MAUDE report 8760345 ↗