PillCam FGS-0591Recalls & reported problems
Given Imaging, Inc. · sensor array · 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 07290101366355), received between Sep 18, 2026 and Sep 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Ambient Noise 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.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem1
- Insufficient Device Problem Information1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Overheating of Device; Ambient Noise Problem; Insufficient Device Problem Information
It was reported that the belt and the electronic pack were vibrating excessively and it was hot to touch. When looking at the screen, there were times where the icon on the top of screen would switch to red. Took off the belt as did not feel it was safe to keep on the patient. There was no patient or user harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816594 ↗
Other SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE devices
- CapsoCam Plus SV-3Capsovision, Inc. · System, Imaging, Gastrointestinal, Wireless, Capsule1 recall0 reports
- AdvanCE 00711144US Endoscopy · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE40 reports
- PillCam FGS-0501Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE27 reports
- PillCam FGS-0391Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE2 deaths17 reports
- Pillcam FGS-0109Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE13 reports
- PillCam FGS-0400Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE11 reports
- AdvanCE 00711144US Endoscopy · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE10 reports
- Pillcam FGS-0347Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 death10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.