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
- NA 170003-24Nucletron B.V. · System, applicator, radionuclide, remote-controlled2 recalls0 reports
- Flexitron HDR 136149Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall3 reports
- Geneva 152022-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152009-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126023-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152024-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126019-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126022-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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