ActiGraph CentrePoint Insight WatchRecalls & reported problems
Actigraph L.L.C. · The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853048008039), received between Oct 28, 2021 and Oct 28, 2021.
The most frequently reported specific device problem is “Output Problem” (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
Device problems
- Output Problem1
Patient problems
- Electric Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Oct 28, 2021Output Problem
A CUSTOMER (RESEARCH COORDINATOR) INFORMED ACTIGRAPH THAT A PARTICIPANT REPORTED FEELING A "SHOCK" WHILE WEARING THE WRIST-WORN DEVICE ON (B)(6) 2021. THE PARTICIPANT DESCRIBED WALKING FROM ONE ROOM IN THEIR HOME TO ANOTHER AREA WHEN THEY RECEIVED AN UNEXPLAINED "SHOCK RUNNING FROM THE WRIST TO THE ELBOW." THE PARTICIPANT REMOVED THE DEVICE FOR THE REMAINDER OF THE DAY, BUT THEY CHOSE TO WEAR THE DEVICE THE NEXT DAY. AT THE TIME OF THIS EVENT, THE PARTICIPANT HAD BEEN WEARING THE DEVICE FOR APPROXIMATELY 5 MONTHS, FOR 20+ HOURS OF WEAR TIME PER DAY, WITH NO PRIOR ISSUES. THE PARTICIPANT DID NOT SEEK IN-PERSON MEDICAL CARE AT THE TIME OF THIS REPORT, AND THE CLINICAL SITE WILL CONTINUE TO MONITOR AND INVESTIGATE THIS EVENT. ACTIGRAPH HAS DEPLOYED WEARABLE ACTIVITY MONITORS FOR OVER 15 YEARS WITH NO PRIOR REPORTS OF THIS NATURE. THIS DEVICE DESIGN IS TESTED FOR ELECTRICAL SAFETY (IEC 60601) VIA A QUALIFIED THIRD-PARTY VENDOR. THE DEVICE UTILIZES A LOW POWER RECHARGEABLE BATTERY (4.2V) EQUIPPED WITH A SAFETY CIRCUIT TO PREVENT DISCHARGE OCCURRENCE. THE DEVICE WILL BE EVALUATED TO COMPLETE THE INVESTIGATION. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Electric Shock
MAUDE report 12719412 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.