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PillCam RFB-0347Recalls & reported problems

Given Imaging, Inc. · recorder, DR3 refurbished · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290101364221), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Communication or Transmission 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

  • Communication or Transmission Problem1
  • Incorrect Or Inadequate Test Results1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 18, 2018Incorrect Or Inadequate Test Results; Communication or Transmission Problem

    GIVEN PILLCAM AND RECORDER HAD TWO EPISODES WHERE THEY STOPPED COMMUNICATING. A REBOOT WAS PERFORMED FOLLOWING EACH FAILURE WITH THE FIRST RECORDING SESSION LASTING MORE THAN 3 HRS, AND THE SUBSEQUENT SESSION LASTING MORE THAN 1.5 HRS. THIS RESULTED IN AN INCOMPLETE/INCONCLUSIVE TEST RESULT. DIAGNOSIS OR REASON FOR USE: ENDOSCOPY - COLONOSCOPY. "IS THE PRODUCT COMPOUNDED: NO, IS THE PRODUCT OVER-THE-COUNTER: NO."

    Patient problems: No Code Available

    MAUDE report 7613408 ↗

Other SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE devices

All SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.