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TomoSPOT 782Recalls & reported problems

Beekley Corporation · Mole Markers, low-density see-through ring, pinch-free material · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815137020490), received between Jul 3, 2018 and Jul 3, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Nonstandard Device2
  • Signal Artifact/Noise2

Patient problems

  • No Code Available2

Recent adverse event reports

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

  • InjuryJul 3, 2018Signal Artifact/Noise; Nonstandard Device

    A MOLE MARKER CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.

    Patient problems: No Code Available

    MAUDE report 7660244 ↗
  • InjuryJul 3, 2018Signal Artifact/Noise; Nonstandard Device

    A MOLE MARKER CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.

    Patient problems: No Code Available

    MAUDE report 7660242 ↗

Other System, X-Ray, Film Marking, Radiographic devices

All System, X-Ray, Film Marking, Radiographic devices →

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