Flexitron HDR 136149Recalls & reported problems
Nucletron B.V. · Flexitron HDR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717213051126), received between Nov 12, 2019 and Sep 27, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Nov 18, 2019Terminated
A component failure may lead to treatment interruption or incorrect source positioning.
Z-0772-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Connection Problem1
- Improper or Incorrect Procedure or Method1
- Manufacturing, Packaging or Shipping Problem1
- Misassembled1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE USER MISREAD FLEXITRON SPS..
Patient problems: Insufficient Information
MAUDE report 20321937 ↗MalfunctionNov 5, 2020Connection Problem; Manufacturing, Packaging or Shipping Problem; Connection Problem; Manufacturing, Packaging or Shipping Problem
THE CUSTOMER REPORTED THAT THE CHECK CABLE BRACKET TUBE GOT DISCONNECTED FROM THE MOUNTING BLOCK.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10791012 ↗MalfunctionNov 12, 2019Misassembled; Misassembled
ONE CUSTOMER COMPLAINT HAS BEEN REPORTED FROM THE FIELD CONCERNING A SYSTEM IN WHICH THE INTERNAL CHECK CABLE GUIDE MECHANISM FAILED. DUE TO AN OBSTRUCTION DURING THE CHECK CABLE OUT DRIVE, THE INTERNAL GUIDING TUBE BECAME DISPLACED AND THE CHECK CABLE BECAME DAMAGED.
Patient problems: No Information
MAUDE report 9309326 ↗
Other System, applicator, radionuclide, remote-controlled devices
- NA 170003-24Nucletron B.V. · System, applicator, radionuclide, remote-controlled2 recalls0 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
- Geneva 152015-00Nucletron 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 · each recall links to the FDA recall notice
- 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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