PillCam FGS-0155Recalls & reported problems
Given Imaging, Inc. · sensor array, DR2 3-lead · Class 2
All models of PillCam (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290101363200), received between Jun 27, 2018 and Sep 7, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Data 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Data Problem1
- Device Markings/Labelling Problem1
- Failure to Transmit Record1
- Inaccurate Synchronization1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2018Failure to Transmit Record; Inaccurate Synchronization
A PILLCAM CAPSULE ENDOSCOPY WAS PLANNED. THE FIRST PILLCAM WE USED HAD DIFFICULTY SYNCING WITH THE CAPSULE DATA COLLECTING DEVICE, SO A SECOND PILLCAM WAS THEN OBTAINED. THIS SECOND PILLCAM SYNCED WITH THE DEVICE, AND AN UPPER ENDOSCOPY WAS DONE TO PLACE THE PILLCAM. THE NEXT DAY, AFTER THE CAPSULE DATA WAS REVIEWED, IT WAS DISCOVERED THAT THE DATA COLLECTION WAS INCOMPLETE. THERE WERE LARGE SECTIONS WHERE RECORDING APPEARS TO BE MISSING STARTING AT ABOUT 2 HR AND 45 MINS INTO THE STUDY. THEN THE RECORDING RESUMES FOR ABOUT 3 MINS AT 3 HR 12 MINS AND THEN STOPS RECORDING AGAIN AT 3 HR 15 MINS. THE CAPSULE STOPS RECORDING ALTOGETHER AT ABOUT 3 HR 45 MINS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7854718 ↗MalfunctionAug 29, 2018Data Problem
PATIENT WAS SCHEDULED FOR AN M2A STUDY BUT WE WERE UNABLE TO CAPTURE DATA/READ STUDY. PATIENT WILL NEED TO REPEAT STUDY AT DIFFERENT TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7826086 ↗MalfunctionJun 27, 2018Device Markings/Labelling Problem
TWENTY-FOUR HOUR PH BRAVO CAPSULE NOT WORKING ONCE IMPLANTED INTO PATIENT ESOPHAGUS. TRANSISTOR BOX READ" CAPSULE MISMATCH". IT WAS DETERMINED THE CORRECT CAPSULE NUMBER WAS ENTERED AND APPEARED WORKING PRIOR TO ESOPHAGEAL PLACEMENT. A NEW CAPSULE NEEDED TO BE PLACED, WHICH WORKED SUCCESSFULLY USING THE SAME BOX RECORDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7641224 ↗
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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