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microSelectron Digital 106990 (UDI 08717213051140)Recalls & reported problems

Nucletron B.V. · microSelectron Digital · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 08717213051140), received between Aug 18, 2020 and Aug 18, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Crack1
  • Insufficient Device Problem Information1
  • Material Twisted/Bent1

Patient problems

  • Foreign Body In Patient1
  • 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.

  • MalfunctionAug 18, 2020Break; Crack; Material Twisted/Bent; Insufficient Device Problem Information; Break; Crack; Material Twisted/Bent; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT A PROGUIDE OBTURATOR WAS BROKEN IN THE PATIENT BODY.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 10419385 ↗

Other System, applicator, radionuclide, remote-controlled devices

All System, applicator, radionuclide, remote-controlled devices →

Sources and updates

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