NA 03.312.840Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982260956), received between Nov 18, 2020 and Aug 2, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING ROUTINE INSPECTION THE MAXFRAME (TM) RADIOGRAPHIC MARKER WAS FOUND BROKEN IN 2. NO PATIENT INVOLVEMENT NO FURTHER INFORMATION AT THIS TIME. THIS REPORT IS FOR ONE (1) MAXFRAME(TM) RADIOGRAPHIC MARKER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149017 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MAXFRAME (TM) RADIOGRAPHIC MARKER WAS BROKE WHILE BEING WASHED DURING STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MAXFRAME(TM) RADIOGRAPHIC MARKER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10861028 ↗