PillCam FGS-0568Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290101365884), received between Sep 6, 2018 and Jan 17, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2019Signal Artifact/Noise; Insufficient Device Problem Information; Unintended Application Program Shut Down; Signal Artifact/Noise; Insufficient Device Problem Information; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY HAD AN 8-HOUR STUDY WITH GAPS. THE PATIENT EXPERIENCED BURNING SENSATIONS DURING THE DIGESTION PROCESS AND HAD A DIARRHEA FOUR DAYS AFTER THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD THE FIRST BOWEL MOVEMENT APPROXIMATELY 3 HOURS AFTER CAPSULE INGESTION. THE PATIENT HAD KUB X-RAY (KIDNEY, URETER, BLADDER) TO CONFIRM THE CAPSULE EXIT. OTHER THAN THAT, THE PATIENT WAS STABLE. A COPY OF THE STUDY WAS PROVIDED FOR REVIEW, AND TECHNICAL SUPPORT CONFIRMED THE STUDY TIME WAS 4 HOURS AND 55 MINUTES, AND THE ISSUE WAS THE SENSOR BELT. THE RECORDER AND SENSOR BELT WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. THERE WAS NO USER HARM.

  Patient problems: Burning Sensation; Diarrhea; Radiation Exposure, Unintended

  MAUDE report 8258997 ↗
• InjurySep 6, 2018Loss of Power; Defective Device; Unintended Application Program Shut Down; Loss of Power; Defective Device; Unintended Application Program Shut Down

  ACCORDING TO THE REPORTER, THEY PERFORMED AN IN-PATIENT STUDY A FEW DAYS AGO, BUT THE RECORDER SHUT DOWN AFTER A VERY SHORT TIME. THE CUSTOMER NOTICED THAT THE RECORDER WAS OFF. THEY DID NOT ATTEMPT TO BEGIN THE STUDY AGAIN, NOR DID THEY CALL TECHNICAL SUPPORT AT THAT TIME, AS IT WAS OVER THE WEEKEND WHEN THIS OCCURRED. THEY DID DOWNLOAD THE STUDY AND IT WAS APPROXIMATELY 10 MINUTES LONG. THEY ALSO INQUIRED IF IT WAS "SAFE" TO PERFORM A STUDY ON THIS SAME PATIENT TODAY, EVEN THOUGH THEY WERE NOT ABLE TO CONFIRM EXCRETION OF THE CAPSULE. TECHNICAL SUPPORT INFORMED THEM THAT IT WAS MORE THAN LIKELY THAT THE CAPSULE BATTERY HAD DIED, BUT IS STILL BETTER TO CONFIRM THE CAPSULE HAS PASSED BY X-RAY IF NECESSARY. THE CUSTOMER UPDATED THAT AN X-RAY HAS BEEN PERFORMED IN TWO DIFFERENT DAYS, AND IT BOTH SHOWED THE CAPSULE WAS STILL INTACT IN THE PATIENT'S GASTROINTESTINAL TRACT. A COPY OF THE STUDY WILL BE SENT IN FOR REVIEW. THE RECORDER AND SENSOR BELT WORKED CORRECTLY DURING THE PREVIOUS PROCEDURE. TECHNICAL SUPPORT REVIEWED THE STUDY AND THE SENSOR BELT CAUSE THE GAPS AD THE STUDY ENDED PREMATURELY. THERE WERE SEVERAL INSTANCES OF "ENERGY TOO LOW/HIGH." THERE WAS NO REPORTED PATIENT OUTC

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7852907 ↗