NA 170607-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717213052758), received between Oct 1, 2021 and Oct 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K121448, K132816); they may or may not involve this specific model.

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.

Recalls naming this device

1. Dec 5, 2022Open, Classified

   A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

   Z-0719-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Oct 13, 2021Open, Classified

   Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

   Z-0182-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2021Computer Software Problem; Computer Software Problem

  ONCENTRA BRACHY OFFERS APPLICATOR MODELLING FUNCTIONALITY, WHICH AIDS THE END-USER IN THE RECONSTRUCTION OF AN ENTIRE APPLICATOR GEOMETRY BY USING ANCHOR POINTS. DURING THE ROOT CAUSE ANALYZE OF A REPORTED CUSTOMER COMPLAINT, UNIQUE SCENARIO'S HAVE BEEN IDENTIFIED THAT COULD POTENTIALLY LEAD TO THE APPLICATOR TO BE MIRRORED. THE ERROR CONDITION WAS FIRST DETECTED BY THE (B)(4) ENGINEERING TEAM ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561892 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121448, K132816. One submission often covers many models, so check the product and lot details in each record.

• Z-0050-2018 · Aug 10, 2017 · Terminated
  Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiati
• Z-0987-2017 · Dec 23, 2016 · Terminated
  Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the
• Z-0604-2016 · Dec 18, 2015 · Terminated
  Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radia
• Z-1712-2015 · May 21, 2015 · Terminated
  Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.