NA 170003-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717213052314), received between Oct 12, 2021 and Dec 20, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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 18, 2026.

Recalls naming this device

1. Dec 5, 2022Class IIOpen, 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, 2021Class IIOpen, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THEY HAD A MISADMINISTRATION INVOLVING ONCENTRA AND FLEXITRON UNIT.

  Patient problems: Insufficient Information

  MAUDE report 16014803 ↗
• InjuryOct 12, 2021Use of Device Problem; Product Quality Problem; Use of Device Problem

  THE CUSTOMER REPORTED POSSIBLE CATHETER RECONSTRUCTION ISSUE WITH SAVI PLANS.

  Patient problems: Insufficient Information; Radiation Burn

  MAUDE report 12613703 ↗

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.