Class II — Nucletron BV
| Recalling firm | Nucletron B.V. |
|---|---|
| Registered facility | NUCLETRON B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect source step size may occur in the software 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 plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel. |
| Quantity | 89 customer sites have the affected software |
| Distribution | Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Nether… |
| Initiated | 2017-08-10 |
| Classified | 2017-10-26 |
| Terminated | 2020-11-20 |
| Recall number | Z-0050-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nucletron BV (Z-0050-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78087/
Alerts for Nucletron B.V.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.