# FDA recall Z-0050-2018

> **Nucletron BV** · Class II · device recall initiated 2017-08-10.

## 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.

## Reason for recall

Incorrect source step size may occur in the software plans

## 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, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland,  Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam.    There was no military/government distribution.

## Key facts

- **Recall number:** Z-0050-2018
- **Recalling firm:** Nucletron BV
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-10
- **Report date:** 2017-11-01
- **Termination date:** 2020-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Veenendaal, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2018

## Citation

> AI Analytics. FDA recall Z-0050-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0050-2018. Source: US FDA. Licensed CC0.

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