Pillcam FGS-0362Recalls & reported problems
Given Imaging, Inc. · recorder accessories, DR3 · Class 2
All models of PillCam (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07290101362975), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Smoking” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Smoking1
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.
MalfunctionApr 30, 2025Smoking; Smoking
IT WAS REPORTED THAT THE CUSTOMER WAS HAVING PROBLEMS GETTING THE CRADLE TO POWER ON. POWER CORDS OF THE CRADLE WERE CHANGED AND THE CRADLE STARTED TO SMOKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937420 ↗
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
- Pillcam FGS-0347Given Imaging, Inc. · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE1 death10 reports
- AdvanCE 00711144US Endoscopy · SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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