ENDOCAPSULE RECORDER RE-10Recalls & reported problems
Olympus Medical Systems Corp. · 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 04953170328244), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (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
- Image Display Error/Artifact1
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.
MalfunctionMar 13, 2024Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED, THE SUBJECT DEVICE DISPLAYED A 0135005-ERROR MESSAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18899498 ↗
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- 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.