The Recall Desk

Manufacturer

Nucletron BV

2 recalls in our database name Nucletron BV as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2020-01-08

Of the 2 recalls from Nucletron BV we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0772-2020·2020-01-08

    Nucletron Flexitron Brachytherapy Afterloader Recalled for Cable Guide Failure

    Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.

    Product
    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This is
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0050-2018·2017-11-01

    Nucletron Oncentra Brachy 4.5 Software Recalled for Incorrect Source Step Size

    Nucletron BV is recalling Oncentra Brachy 4.5 radiation therapy software because incorrect source step sizes may occur in treatment plans.

    Product
    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 radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide