Flex-X / IMAGE 1 S 11278VSURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551344385), received between Dec 29, 2025 and Sep 2, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Apr 1, 2022Open, Classified

   Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

   Z-1070-2022 · Root cause: Under Investigation by firm · FDA record ↗

2. Apr 1, 2022Open, Classified

   Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

   Z-1069-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionSep 2, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571550 ↗
• MalfunctionDec 29, 2025Temperature Problem; Insufficient Device Problem Information; Temperature Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SCOPE STOPPED WORKING MID CASE. THE SURGEON BELIEVES THIS IS BECAUSE OF THE INCORRECT DEFLECTION MECHANISM. THE CASE HAD TO BE ABANDONED AS THEY DID NOT HAVE A SPARE SCOPE.

  Patient problems: Insufficient Information

  MAUDE report 23917743 ↗